Clinical Trial Results:
A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
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Summary
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EudraCT number |
2014-003608-61 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
24 Nov 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jul 2016
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First version publication date |
06 Aug 2015
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Other versions |
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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 |
ZLB06_002CR
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01199705 | ||
WHO universal trial number (UTN) |
U1111-1116-6379 | ||
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Sponsors
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Sponsor organisation name |
CSL Behring K.K.
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Sponsor organisation address |
1-13-1 Kachidoki, Chuo-ku, Tokyo, Japan, 104-0054
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Public contact |
Trial Registration Co-ordinator, CSL Behring, clinicaltrials@cslbehring.com
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Scientific contact |
Trial Registration Co-ordinator, CSL Behring, 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? |
Yes
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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 2012
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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 |
24 Nov 2011
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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 objective of this study was to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study assessed the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.
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Protection of trial subjects |
The study was conducted in accordance with the principles of the Ministry of Health and Welfare notification #28 (GCP, 27 March 1997) and YakuShokuShinsaHatsu Notification#1001001 (1 October 2000). The study was also carried out in keeping with requirements set forth in Pharmaceutical Affairs Law 14-3 and 80-2. In addition, this study was conducted in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and standard operating procedures for clinical research and development at CSL Behring and the Clinical Research Organisations involved. GCP compliance was assessed during data review and confirmed in the Data Review Meeting. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki (version of 2008). The study was conducted under a protocol reviewed and approved by an Independent Ethics Committee/Institutional Review Board; the study was conducted by scientifically and medically qualified persons; the benefits of the study were in proportion to the risks; the rights and welfare of the subjects were respected; the physicians conducting the study did not find the hazards to outweigh the potential benefits; the results reported are accurate.
The investigator was responsible for obtaining written informed consent from the participating subject in accordance with Ministry of Health and Welfare notification #28 (GCP, 27 March 1997) and in compliance with the Declaration of Helsinki. Each subject and/or subject’s parent or legal guardian gave his or her written informed consent before any protocol-driven tests or evaluations were performed. The investigator could cease study treatment and withdraw the subject, or the subject could withdraw themselves from participation in the study at any time. The decision to withdraw consent and discontinue participation in the study could not prejudice the subject’s future medical treatment in any way.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Sep 2010
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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 |
Japan: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
0
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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) |
7
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Adolescents (12-17 years) |
5
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Adults (18-64 years) |
13
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This multicenter study enrolled subjects at nine of the participating study centers in Japan. | ||||||||||||||||
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Pre-assignment
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Screening details |
Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Overall trial | ||||||||||||||||
Arm description |
The study consisted of an intravenous immunoglobulin (IVIG) treatment period with 3 infusions, a 12-week subcutaneous immunoglobulin (SCIG) wash-in/washout period, and a 12-week SCIG efficacy period (i.e. 24 weeks of SCIG treatment with IgPro20): • IVIG treatment: Study subjects continued their previous IVIG therapy regimen with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). • SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. • SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Immune Globulin Subcutaneous (Human) (SCIG)
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Investigational medicinal product code |
IgPro20
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Other name |
Hizentra, Human Normal Immunoglobulin
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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 |
IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human SCIG. Subjects receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
The study consisted of an intravenous immunoglobulin (IVIG) treatment period with 3 infusions, a 12-week subcutaneous immunoglobulin (SCIG) wash-in/washout period, and a 12-week SCIG efficacy period (i.e. 24 weeks of SCIG treatment with IgPro20): • IVIG treatment: Study subjects continued their previous IVIG therapy regimen with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). • SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. • SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
The study consisted of an intravenous immunoglobulin (IVIG) treatment period with 3 infusions, a 12-week subcutaneous immunoglobulin (SCIG) wash-in/washout period, and a 12-week SCIG efficacy period (i.e. 24 weeks of SCIG treatment with IgPro20): • IVIG treatment: Study subjects continued their previous IVIG therapy regimen with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). • SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. • SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. | ||
Subject analysis set title |
IgPro20 - Per Protocol Set (PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
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Subject analysis set title |
IgPro20 - Full Analysis Set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
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Subject analysis set title |
IVIG Treatment (PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks). The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
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Subject analysis set title |
SCIG Treatment (Wash-in/Wash-out)(PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period (weeks 1 to 12). The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
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Subject analysis set title |
SCIG Treatment (Efficacy)(PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Weekly SC IgPro20 infusions for a 12-week efficacy period (weeks 13 to 24). The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
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Subject analysis set title |
IVIG Treatment (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks). The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
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Subject analysis set title |
SCIG Treatment (Wash-in/Wash-out)(FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period (weeks 1 to 12). The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
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Subject analysis set title |
SCIG Treatment (Efficacy)(FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Weekly SC IgPro20 infusions for a 12-week efficacy period (weeks 13 to 24). The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
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Subject analysis set title |
IVIG Treatment (SDS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks). The safety data set (SDS) comprised all subjects treated with the study drug.
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Subject analysis set title |
SCIG Treatment (SDS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment. The safety data set (SDS) comprised all subjects treated with the study drug.
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End point title |
IgG Trough Level [1] | ||||||||||||
End point description |
Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.
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End point type |
Primary
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End point timeframe |
During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24
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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: The statistical analysis for this endpoint, being the comparison of the geometric mean trough level of the IVIG and SCIG groups, calculated as a ratio with an associated 90% confidence interval and presented herein, was the primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Infection Episodes (Serious and Non-serious) by Study Period | ||||||||||||||||||
End point description |
Number of infection episodes (serious and non-serious) presented by study period:
•IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
•SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
•SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
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End point type |
Secondary
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End point timeframe |
Up to 36 weeks
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population | ||||||||||||||||
End point description |
The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
•IVIG treatment (up to 12 weeks)
•SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
•SCIG IgPro20 treatment (efficacy) (12 weeks)
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End point type |
Secondary
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End point timeframe |
Up to 36 weeks
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| Notes [2] - Number of Subject Study Days Analyzed: 1209 [3] - Number of Subject Study Days Analyzed: 1764 [4] - Number of Subject Study Days Analyzed: 1840 |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population | ||||||||||||||||
End point description |
The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
•IVIG treatment (up to 12 weeks)
•SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
•SCIG IgPro20 treatment (efficacy) (12 weeks)
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End point type |
Secondary
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End point timeframe |
Up to 36 weeks
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| Notes [5] - Number of Subject Study Days Analyzed = 1396 [6] - Number of Subject Study Days Analyzed = 2016 [7] - Number of Subject Study Days Analyzed = 2095 |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | |||||||||||||||||||||
End point description |
Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
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End point type |
Secondary
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End point timeframe |
Up to 36 weeks
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of Days of Hospitalization Due to Infections by Study Period | |||||||||||||||||||||
End point description |
Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
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End point type |
Secondary
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End point timeframe |
Up to 36 weeks
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | |||||||||||||||||||||
End point description |
Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
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End point type |
Secondary
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End point timeframe |
Up to 36 weeks
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Rate of All Adverse Events by Relatedness and Seriousness | ||||||||||||||||||||||||
End point description |
The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
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End point type |
Secondary
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End point timeframe |
For the duration of the study, up to 36 weeks
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| Notes [8] - Number of infusions analyzed: 75 [9] - Number of infusions analyzed: 584 |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Rate of Mild, Moderate, or Severe Local Reactions | |||||||||||||||||||||
End point description |
In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.
Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity.
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End point type |
Secondary
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End point timeframe |
For the duration of the study, up to 36 weeks
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| Notes [10] - Number of infusions analyzed: 75 [11] - Number of infusions analyzed: 584 |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population | ||||||||||||||||
End point description |
The annualized rate was based on the total number of SBIs and the total number of subject study days
for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365
days.
Study periods:
•IVIG treatment (up to 12 weeks)
•SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
•SCIG IgPro20 treatment (efficacy; 12 weeks)
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End point type |
Other pre-specified
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End point timeframe |
Up to 36 weeks
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| Notes [12] - Number of subject days analyzed: 1209 [13] - Number of subject days analyzed: 1764 [14] - Number of subject days analyzed: 1840 |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population | ||||||||||||||||
End point description |
The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.
Study periods:
•IVIG treatment (up to 12 weeks)
•SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
•SCIG IgPro20 treatment (efficacy; 12 weeks)
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End point type |
Other pre-specified
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End point timeframe |
Up to 36 weeks
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| Notes [15] - Number of subject days analyzed: 1396 [16] - Number of subject days analyzed: 2016 [17] - Number of subject days analyzed: 2095 |
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
For the duration of the study, up to 36 weeks
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Adverse event reporting additional description |
Safety data set (SDS) comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
IVIG Treatment (SDS)
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Reporting group description |
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks). The safety data set (SDS) comprised all subjects treated with the study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SCIG Treatment (SDS)
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Reporting group description |
IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment. The safety data set (SDS) comprised all subjects treated with the study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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09 Jun 2010 |
The first amendment (i.e., version 2.0) was dated 09 June 2010. The rationale for this amendment were changes based on discussions with the PMDA, updates to the original study concept to reflect the current scientific knowledge in PID treatment, and experience from ongoing or completed CSL Behring studies with IgPro20 in regions outside of Japan. |
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09 Sep 2010 |
The rationale for the 2nd and final amendment (i.e., version 3.0) was to incorporate changes based on further discussions with the PMDA during the 30-days review period. All subjects in the study were treated according to this study protocol. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
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 | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/25236916 http://www.ncbi.nlm.nih.gov/pubmed/24504846 |
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