NCT00244257

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

Phase I, Open-Label, Multi-center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	GMA161	0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
BIOLOGICAL	GMA161	0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
BIOLOGICAL	GMA161	0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
BIOLOGICAL	GMA161	1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
BIOLOGICAL	GMA161	3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2005-10-26
• Last updated: 2015-04-09

Locations

6 sites across 1 country: United States