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

Octapharma

Status and phase: Completed; Phase 3

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: Octagam 10%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426270

GAM10-02

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Octagam 10% 1 g/kg/day

Experimental group

Description:

Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.

Treatment:

Drug: Octagam 10%