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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase I, Open-Label, Multi-center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiop

Brief 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.

Detailed Summary:
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome: Evaluate safety, tolerability and pharmacokinetics (PK) of single intravenous (IV) infusions of GMA161 in patients with idiopathic thrombocytopenic purpura (ITP) [ Time Frame: up to 3 years ]

Original Primary Outcome: Evaluate safety, tolerability and PK if single IV infusions of GMA161 in patients with ITP

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: October 25, 2005
Date Started: August 2005
Date Completion:
Last Updated: April 8, 2015
Last Verified: April 2015