drugset / Trial / NCT00504075

A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

NCT00504075

Phase 3 Completed 35 enrolled Bio Products Laboratory
NaSingle-groupOpen-labelTreatment

Summary

To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response \>60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.

Timeline

Start
2007-09
Primary completion
2011-08
Completion
2011-08

Drugs

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