AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

March 29, 2005

Primary Completion Date

September 1, 2006

Study Completion Date

March 1, 2007

Conditions
ThrombocytopeniaIdiopathic Thrombocytopenic Purpura
Interventions
DRUG

Placebo

Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.

BIOLOGICAL

AMG 531

Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY