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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
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
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1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
Unnamed facility
New York, New York, United States
Unnamed facility
Cleveland, Ohio, United States