drugset / Trial / NCT00168038

Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10

NCT00168038

Phase 3 Completed 58 enrolled CSL Behring
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10\^9/L.

Timeline

Start
2004-12
Primary completion
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 1 g/kg Intravenous