Clinical Trial Results:
Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults.
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Summary
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EudraCT number |
2005-003552-35 |
Trial protocol |
DE AT CZ FR |
Global end of trial date |
15 Sep 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Dec 2016
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First version publication date |
03 Dec 2016
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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 |
GAM10-02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00426270 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Octapharma AG
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Sponsor organisation address |
Seidenstrasse 2, Lachen, Switzerland, CH-8853
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Public contact |
Octapharma Pharmazeutika Prod.Ges.m.b.H., Octapharma Pharmazeutika Prod.Ges.m.b.H., 0043 1 610 32 0,
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Scientific contact |
Octapharma Pharmazeutika Prod.Ges.m.b.H., Octapharma Pharmazeutika Prod.Ges.m.b.H., 0043 1 610 32 0,
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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 |
02 Jun 2009
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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 |
15 Sep 2008
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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 main objective of the study is to investigate the efficacy of Octagam® 10% in correcting the platelet count.
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Protection of trial subjects |
This trial was conducted in accordance to the principles of GCP, ensuring that the rights, safety and wellbeing of patients are protected and in consistency with the Declaration of Helsinki. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and safety factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs, lab values, vital signs and physical examinations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Jun 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Austria: 1
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Country: Number of subjects enrolled |
Czech Republic: 27
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Germany: 18
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Country: Number of subjects enrolled |
Poland: 69
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Worldwide total number of subjects |
116
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EEA total number of subjects |
116
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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) |
1
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Adults (18-64 years) |
91
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From 65 to 84 years |
22
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85 years and over |
2
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Recruitment
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Recruitment details |
- | ||||||||||||
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Pre-assignment
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Screening details |
In total, 116 subjects were enrolled in the study in order to achieve 110 evaluable subjects with acute or chronic ITP. | ||||||||||||
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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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Octagam 10% | ||||||||||||
Arm description |
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Octagam 10%
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Investigational medicinal product code |
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Other name |
Human Normal Immunoglobulin
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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 |
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Octagam 10%
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Reporting group description |
Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days | ||
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End point title |
Percentage of Participants with a Clinical Response [1] | ||||||||
End point description |
A clinical response is defined as an increase in platelet count to ≥ 50 x 10^9/L on any day from Day 2 to Day 7.
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End point type |
Primary
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End point timeframe |
Day 2 to Day 7
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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 of the primary endpoint comprised the overall response rate in the full analysis set and the associated two-sided 95% confidence interval, and is given in the end point values table. |
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| Notes [2] - One participant was incorrectly enrolled in the study and was not included in the efficacy analyses |
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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 |
The condition of the patients were monitored until day 21
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Adverse event reporting additional description |
Safety population: All participants who received at least 1 dose of study medication.
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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 |
9.0
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Reporting groups
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Reporting group title |
Safety Set
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Reporting group description |
All participants who received at least 1 dose of study medication | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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08 May 2006 |
Amendment #2
1. If a subject was hospitalised before study drug treatment due to the underlying disease, or hospitalised for social reasons or for an elective procedure, this was not to be reported as an SAE.
2. If a study site was inactive and did not screen any subjects for the study, the monitor did not need to perform a trial termination visit.
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21 Aug 2006 |
Amendment #3:
1. The descriptive interim analysis after recruitment of 30 subjects, described in the interim report dated 26 September 2007, was added to the protocol, in order to obtain marketing authorisation in Europe. |
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13 Oct 2006 |
Amendment #4:
1. The permitted and forbidden prior and concomitant medications were clarified.
2. Faster infusion rates were added (up to 0.12 mL/kg/min), to allow shorter infusion times for subjects who tolerated the Octagam 10% infusions well.
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09 Mar 2007 |
Amendment #6:
1. Additional viral marker testing for HIV, HCV and HBV was added, to fulfil FDA requirements.
2. Deletion of possible sample size adaptation after interim analysis as requested by the FDA; total recruitment target remained at 110 subjects.
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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 | |||
