Clinical Trial Results:
A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc)
Summary
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EudraCT number |
2018-003149-41 |
Trial protocol |
DE FR GB IT |
Global end of trial date |
17 May 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Jun 2023
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First version publication date |
23 Jun 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
IgPro20_2001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04137224 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
CSL Behring
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Sponsor organisation address |
Emil-von-Behring-Strasse 76, Marburg, Germany, 35041
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Public contact |
Trial Registration Coordinator, CSL Behring LLC, +1 610-878-4000, clinicaltrials@cslbehring.com
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Scientific contact |
Trial Registration Coordinator, CSL Behring LLC, +1 610-878-4000, clinicaltrials@cslbehring.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 May 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 May 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study was to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in subjects with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aim was to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in subjects with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 was also evaluated.
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Protection of trial subjects |
This study was carried out in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and standard operating procedures for clinical research and development at CSL Behring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Sep 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 17
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Country: Number of subjects enrolled |
United Kingdom: 6
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Country: Number of subjects enrolled |
Germany: 1
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Australia: 2
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Worldwide total number of subjects |
27
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EEA total number of subjects |
19
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at study centers in Australia, Germany, Italy, Poland, and the United Kingdom from 19 September 2019 to 17 May 2022. | |||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 30 subjects were screened, of which 27 subjects were enrolled and randomised to Sequence A or Sequence B in this study. | |||||||||||||||||||||
Period 1
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Period 1 title |
Treatment Period 1 (Week 1 to Week 16)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sequence A (IgPro20/IgPro10) | |||||||||||||||||||||
Arm description |
Subjects received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
IgPro20
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Investigational medicinal product code |
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Other name |
Hizentra
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.
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Investigational medicinal product name |
IgPro10
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Investigational medicinal product code |
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Other name |
Privigen
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.
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Arm title
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Sequence B (IgPro10/IgPro20) | |||||||||||||||||||||
Arm description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
IgPro10
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Investigational medicinal product code |
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Other name |
Privigen
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.
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Investigational medicinal product name |
IgPro20
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Investigational medicinal product code |
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Other name |
Hizentra
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.
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Period 2
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Period 2 title |
Treatment Period 2 (Week 17 to Week 32)
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sequence A (IgPro20/IgPro10) | |||||||||||||||||||||
Arm description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
IgPro20
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Investigational medicinal product code |
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Other name |
Hizentra
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.
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Investigational medicinal product name |
IgPro10
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Investigational medicinal product code |
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Other name |
Privigen
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.
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Arm title
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Sequence B (IgPro10/IgPro20) | |||||||||||||||||||||
Arm description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
IgPro10
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Investigational medicinal product code |
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Other name |
Privigen
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
A total dose of 2 g/kg was administered over 2-5 sessions on consecutive days every 4 weeks for up to 16 weeks.
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Investigational medicinal product name |
IgPro20
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Investigational medicinal product code |
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Other name |
Hizentra
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
A total dose of 0.5 g/kg was administered over 2 sessions per week for up to 16 weeks.
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Notes [1] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero. Justification: 13 subjects have started and completed the sequence A in treatment period 2. |
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Baseline characteristics reporting groups
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Reporting group title |
Sequence A (IgPro20/IgPro10)
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Reporting group description |
Subjects received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sequence B (IgPro10/IgPro20)
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Reporting group description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Sequence A: IgPro10
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.
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Subject analysis set title |
Sequence A: IgPro20
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.
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Subject analysis set title |
Sequence B: IgPro10
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.
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Subject analysis set title |
Sequence B: IgPro20
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
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End points reporting groups
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Reporting group title |
Sequence A (IgPro20/IgPro10)
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Reporting group description |
Subjects received IgPro20 of a total dose of 0.5 grams per kilogram (g/kg) over 2 sessions per week as a subcutaneous (SC) injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an intravenous (IV) infusion for up to 16 weeks in Treatment Period 2. | ||
Reporting group title |
Sequence B (IgPro10/IgPro20)
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Reporting group description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | ||
Reporting group title |
Sequence A (IgPro20/IgPro10)
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Reporting group description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1 followed by IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2. | ||
Reporting group title |
Sequence B (IgPro10/IgPro20)
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Reporting group description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1 followed by IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | ||
Subject analysis set title |
Sequence A: IgPro10
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2.
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Subject analysis set title |
Sequence A: IgPro20
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1.
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Subject analysis set title |
Sequence B: IgPro10
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1.
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Subject analysis set title |
Sequence B: IgPro20
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2.
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End point title |
Number of Subjects With at Least one Adverse Event (AE) for IgPro20 [1] | |||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
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End point type |
Primary
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End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With at Least one AE for IgPro20 [2] | ||||||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
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End point type |
Primary
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End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With at Least one Treatment-Emergent Adverse Event (TEAE) for IgPro20 [3] | |||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
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End point type |
Primary
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End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With at Least one TEAE for IgPro20 [4] | ||||||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
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End point type |
Primary
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End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With at Least one Serious Adverse Event (SAE) for IgPro20 [5] | |||||||||
End point description |
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
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End point type |
Primary
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End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With at Least one SAE for IgPro20 [6] | ||||||||||||
End point description |
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
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End point type |
Primary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With at Least one Adverse Events of Special Interest (AESI) for IgPro20 [7] | |||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With at Least one AESI for IgPro20 [8] | ||||||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With AEs Categorized as Infusion Site Reactions (ISRs) for IgPro20 [9] | |||||||||
End point description |
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With AEs Categorized as ISRs for IgPro20 [10] | ||||||||||||
End point description |
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Rate of ISRs per Infusion for IgPro20 [11] | ||||||||||||
End point description |
ISR rate per infusion = total number of ISRs across all subjects while on IgPro20 / total number of IgPro20 Infusions across all subjects. ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 and with ISRs were analysed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
|||||||||||||
|
|||||||||||||
Notes [12] - Overall Number of Units Analysed: 353 Infusions [13] - Overall Number of Units Analysed: 333 Infusions |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Time to Onset of ISRs for IgPro20 [14] | ||||||||||||
End point description |
ISRs included all events reported within the MedDRA High-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Time to onset of ISR since the start of the treatment period was reported.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
|||||||||||||
|
|||||||||||||
Notes [15] - Overall Number of Units Analysed: 2 ISRs [16] - Overall Number of Units Analysed: 12 ISRs |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Duration of ISRs for IgPro20 [17] | ||||||||||||
End point description |
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 and with ISRs were analysed.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
|||||||||||||
|
|||||||||||||
Notes [18] - Overall Number of Units Analysed: 2 ISRs [19] - Overall Number of Units Analysed: 12 ISRs |
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in Laboratory Tests for IgPro20 [20] | |||||||||
End point description |
Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3/>16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential<40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%;Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and TotalBilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine,serum>1.5xbaseline assessment/change >0.3mg/dL;Glucose,blood:<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN;Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL.Safety set.Subjects who received IgPro20 were analysed.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Up to last follow up visit (approximately 36 weeks)
|
|||||||||
Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Changes in Vital Signs for IgPro20 [21] | |||||||||
End point description |
Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead).
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro20 were analysed.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters for IgPro20 [22] | |||||||||
End point description |
Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro20 were analysed.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in Pulmonary Function Tests (PFTs) for IgPro20 [23] | |||||||||
End point description |
PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than 10 percentage points from the reference visit. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro20 were analysed.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only the descriptive analysis was planned to be reported for this endpoint. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Relative Bioavailability (%F) of IgPro20 | ||||||||||||
End point description |
Relative bioavailability was calculated using Mixed Model Repeated Measures on Log-transformed Dose-normalized area under the curve to the end of the dosing period [AUC0-tau] following administration of the first dose of IgPro20 in the last week of dosing for Sequence A and / or Sequence B. Relative Bioavailability= (AUCtau IgPro20 (SC)/dose of IgPro20 (SC) / (AUCtau of IgPro10 (IV)/dose of IgPro10 (IV)). Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Area Under the Concentration Curve to the end of the Dosing Period (AUC0-tau) for IgPro20 | ||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro20 | ||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Plasma Drug Concentration (Cmax) for IgPro20 | ||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A-(Pre-injection [inj] at Weeks [Wks] 1,5,9,13,14; 24,48,72,96,168 hours [hrs] post 1st inj at Wk 14; 240 hrs post 1st inj at Wk 15), Seq B-(Pre-inj at Wks 17,21,25,29,30; 24,48,72,96,168 hrs post 1st inj at Wk 30; 240 hrs post 1st inj at Wk 31)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Area Under the Concentration Curve to the End of the Dosing Period (AUC0-tau) for IgPro10 | ||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro10 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Area Under the Concentration Curve up to the Last Measurable Concentration (AUC0-last) for IgPro10 | ||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro10 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Plasma Drug concentration (Cmax) for IgPro10 | ||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Number of subjects analysed indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Seq A and B respectively-Pre-infusion (inf) at Wks 17,21,25,29 and 1,5,9,13; 1 hour (hr) post 1st and 2nd inf, 168 hr post 1st inf at Wk 29,13; 264 and 336 hr post 1st inf at Wk 30, 14; 504 hr post 1st inf at Wk 31,15; 672 hr post 1st inf at Wk 32,16
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With at Least one AE for IgPro10 | |||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With at Least one AE for IgPro10 | ||||||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With at Least one TEAE for IgPro10 | |||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With at Least one TEAE for IgPro10 | ||||||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs are defined as AEs reported at or after the start of the first infusion in the study.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With at Least one SAE for IgPro10 | |||||||||
End point description |
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With at Least one SAE for IgPro10 | ||||||||||||
End point description |
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With at Least one AESI for IgPro10 | |||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With at Least one AESIs for IgPro10 | ||||||||||||
End point description |
AE is any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An AESI is an AE of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is appropriate.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With AEs Categorized as ISRs for IgPro10 | |||||||||
End point description |
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With AEs Categorized as ISRs for IgPro10 | ||||||||||||
End point description |
ISRs included all events reported within the MedDRA high-level terms 'Administration site reactions', 'Infusion site reactions', or 'Injection site reactions'.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in Laboratory Tests for IgPro10 | |||||||||
End point description |
Abnormality criteria:Hematology-Hemoglobin:<10 g/dL;Platelet count:<75x10^9/L or >500x10^9/L;White Blood Cell Count:<3/>16x10^9/L;Neutrophils:absolute <1.5x10^9/L,differential<40%;Lymphocytes:absolute <0.8x10^9/L,differential <10 or >50%;Biochemistry-Bilirubin:>1.5xupper limit of normal (ULN);Alkaline phosphatase:>2.5xULN;Serum Glutamic-oxalacetic transaminase(SGOT), Aspartate transaminase(AST):>3xULN;Serum glutamic-pyruvic transaminase(SGPT), Alanine transaminase(ALT):>3xULN;Screening:AST/ALT >3xULN and TotalBilirubin >2xULN;Urea nitrogen:>2.5xULN; Creatinine,serum>1.5xbaseline assessment/change >0.3mg/dL;Glucose,blood:<55/>160mg/dL;Calcium:<7/>11.5mg/dL;Total protein: <5/>9g/dL; Albumin:<3g/dL;Sodium:<130/>150mmol/L;Potassium:<3/>5.5mmol/L; Uric acid,serum:>10mg/dL Males,>8mg/dL Females;Gamma Glutamyl Transpeptidase:>2.5xULN;Phosphorus,inorganic:<2.5/>5mg/dL;Lactate dehydrogenase:>3xULN;Urinalysis-Protein:>20mg/dL.Safety set.Subjects who received IgPro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Changes in Vital Signs for IgPro10 | |||||||||
End point description |
Clinically significant abnormality criteria for vital signs included Systolic blood pressure (BP): <100 millimeters of mercury (mmHg) or ≥140 mmHg or ≥140 mmHg and increase >10 from reference visit; Diastolic BP: <50 mmHg or ≥90 mmHg or ≥90 mmHg and increase >10 from reference visit; Pulse rate: <50 beats/minute or ≥120 beats/minute or ≥120 beats/minute and increase >15 from reference visit; Weight (kilograms) ≥10% change (increase and decrease) from baseline assessment; Body temperature: > 39-degree Celsius (°C ) or <35°C (oral, tympanic, axilla or forehead).
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in ECG Parameters for IgPro10 | |||||||||
End point description |
Clinically significant abnormality criteria for ECG parameters included Heart rate: ≤50 or ≥100 beats/minute; PR Interval: ≥200 millisecond (msec); QRS Interval: ≥120 msec; QT: ≥480 msec; QT interval corrected using Bazett' s formula (QTcB): ≤ 500 msec; QT interval corrected using Fridericia's formula (QTcF): >500 msec; QT: increase from baseline ≥ 30; QTcB: increase from baseline < 60 msec; QTcF: increase from baseline ≥ 60.
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of Subjects With Clinically Significant Abnormalities in PFTs for IgPro10 | |||||||||
End point description |
PFTs include Spirometry which included forced vital capacity (FVC) % Predicted, considered as clinically significant abnormality when decrease is greater than 10 percentage points from the reference visit. Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received Ig Pro10 were analysed.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug through last follow-up visit (up to 36 weeks)
|
|||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence A | ||||||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro20 were analysed. ‘Number analysed (n)’ indicates the number of subjects with data available for analysis at the specified time point.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Pre-injection in Weeks 5, 9, 13 and 14
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Minimum Plasma Drug Concentration (Ctrough) for IgPro20 in Sequence B | ||||||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. ’Number of subjects analysed’ indicates the number of subjects who received IgPro20 and with data available for endpoint analysis.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Pre-injection at Week 21, 25, 29, and 30
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||
End point title |
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence A | ||||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. Subjects who received IgPro10 were analysed. ‘Number analysed (n)’ indicates the number of subjects with data available for analysis at the specified time point.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Pre-infusion at Weeks 21, 25 and 29
|
||||||||||||||
|
|||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||
End point title |
Minimum Plasma Drug Concentration (Ctrough) for IgPro10 in Sequence B | ||||||||||||||
End point description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10. 'Number of subjects analysed’ indicates the number of subjects who received IgPro10 and with data available for endpoint analysis. 'Number analysed (n)’ indicates the number of subjects with data available for analysis at the specified time point.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Pre-infusion at Week 5, 9 and 13
|
||||||||||||||
|
|||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Rate of ISRs per Subject for IgPro20 | ||||||||||||
End point description |
9999= Data was not collected for this endpoint.
|
||||||||||||
End point type |
Other pre-specified
|
||||||||||||
End point timeframe |
From first dose of study drug through last follow up visit (up to 36 weeks)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first dose of study drug through last follow up visit (up to 36 weeks)
|
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Adverse event reporting additional description |
Safety analysis set included all subjects who received at least 1 infusion of IgPro20 or IgPro10.
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
|
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Reporting groups
|
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Reporting group title |
Sequence A: IgPro10
|
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Reporting group description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sequence A: IgPro20
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Reporting group description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sequence B: IgPro10
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Reporting group description |
Subjects received IgPro10 of a total dose of 2 g/kg over 2-5 sessions on consecutive days every 4 weeks as an IV infusion for up to 16 weeks in Treatment Period 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sequence B: IgPro20
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Reporting group description |
Subjects received IgPro20 of a total dose of 0.5 g/kg over 2 sessions per week as a SC injection for up to 16 weeks in Treatment Period 2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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16 Jul 2019 |
• Addition of text regarding identified risk of Thromboembolic events (TEE) in treatment population, including new exclusion criteria, monitoring, and study stopping rules
• Expansion of hemolysis testing as a safety assessment during IgPro20 treatment
• Clarification of timing for study endpoint measures
• Addition of exclusion criterion to address use of contraception by potential male subjects
• Addition of exclusion criteria to address subjects with potential risks of TEE
• Addition of deoxy ribonucleic acid (DNA) and ribonucleic acid (RNA) as biomarkers and additional collection of whole blood to obtain DNA and RNA
• Addition of TEEs as an AESI. |
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07 Nov 2019 |
• Modification of Primary and Secondary Endpoints to include summaries of TEAEs, SAEs, and AESIs
• Addition of rules for stopping infusion of IgPro20 or IgPro10 and discontinuation of treatment
• Addition of text and assessments to monitor renal safety
• Addition and classification of hemolysis and potential acute renal injury as AESIs
• Addition of guidance regarding the maximum infusion rate for subjects with renal dysfunction
• Addition of maximum doses of IgPro20 and IgPro10, based on body weight
• Removal of DLCO assessment at Baseline
• Clarification of the method of scoring for manual muscle testing
• Addition of interim analysis. |
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21 Oct 2020 |
• Defined adjustments that are effective during the Coronavirus disease 2019 (COVID-19) pandemic and provided detailed guidance and procedures that allowed investigators the flexibility to complete critical protocol safety and efficacy assessments while limiting subject exposure to COVID-19 at study sites. |
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22 Feb 2021 |
• Added guidance regarding dispensing Investigational product (IP) to subjects during a state of emergency or public health crisis
• Added an option for remote visits during a state of emergency or public health crisis
• Revised contingencies that were effective during a state of emergency or a public health crisis. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |