Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Information source: Octapharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immune Thrombocytopenic Purpura
Intervention: Octagam 10% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Octapharma Official(s) and/or principal investigator(s):
Wolfgang Frenzel, MD, Study Director, Affiliation: Octapharma
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 efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic
Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected
that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
Clinical Details
Official title: Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With a Clinical Response
Secondary outcome: Time to Achieve a Clinical ResponseMaximum Platelet Count Duration of the Clinical Response Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
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.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety
was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory
parameters, and by viral safety testing.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Key Inclusion Criteria:
- Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard
criteria.
- Platelet count ≤ 20 x 10^9/L.
Key Exclusion Criteria:
- 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.
Locations and Contacts
Contact Octapharma for information, Vienna, Austria
Additional Information
Starting date: June 2006
Last updated: July 28, 2014
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