A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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|ClinicalTrials.gov Identifier: NCT00504075|
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : June 6, 2012
Last Update Posted : March 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Idiopathic Thrombocytopenic Purpura||Biological: Gammaplex, intravenous immunoglobulin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
|Experimental: Gammaplex (intravenous immunoglobulin)||
Biological: Gammaplex, intravenous immunoglobulin
Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).
The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
Other Name: Gammaplex
- The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L. [ Time Frame: 9 days ]The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.
- The Safety of GAMMAPLEX at the Dosage Used in This Study. [ Time Frame: AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90. ]
The safety variables used to assess safety were the following:
- The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops
- Nature, severity, and frequency of AEs
- Suspected unexpected serious adverse reactions (SUSARs)
- Vital signs
- Clinical laboratory tests and Direct Coombs' Test
- Transmission of viruses
- Physical examination
- Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L. [ Time Frame: Days 1, 2, 3, 5, 9, 14, 21, 32. ]Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504075
|Principal Investigator:||Tim J Aldwinckle, MD||Bio Products Laboratory|