Status:
COMPLETED
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Lead Sponsor:
Octapharma
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the ef...
Detailed Description
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21. ...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
- Platelet count ≤ 20 x 10\^9/L.
- Key
Exclusion
- Chronic refractory ITP patients.
- Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.
- Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment.
- Administration of thrombocyte concentrates within 72 hours before baseline.
- Experimental treatment (eg, rituximab) within 3 months before enrollment.
- Prophylactic preoperative treatment for elective splenectomy.
- Severe liver or kidney disease.
- Pregnant or nursing female.
- History of hypersensitivity to blood or plasma derived products.
- Emergency operation.
- Live viral vaccination within the last month prior to study entry.
- Known IgA deficiency and antibodies against IgA.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00426270
Start Date
June 1 2006
End Date
September 1 2008
Last Update
August 1 2014
Active Locations (1)
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1
Contact Octapharma for information
Vienna, Austria