drugset / Trial / NCT00244257

Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

NCT00244257 ↗

Phase 1 Terminated 10 enrolled Genzyme, a Sanofi Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is designed to investigate the safety of a single infusion of GMA161 in patients with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the body. In addition, throughout the study, platelet counts and other blood cell numbers will be measured. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.

Timeline

Start
2005-08
Primary completion
2008-07
Completion
2008-07

Outcome

Outcome not reported

Stopped (Enrollment): “Study terminated due to low enrollment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject GMA161 Unknown 0.1 mg/kg Intravenous
Subject GMA161 Unknown 0.3 mg/kg Intravenous
Subject GMA161 Unknown 0.6 mg/kg Intravenous
Subject GMA161 Unknown 1 mg/kg Intravenous
Subject GMA161 Unknown 3 mg/kg Intravenous