Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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.