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

PHASE3CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

April 7, 2005

Primary Completion Date

December 1, 2006

Study Completion Date

April 1, 2007

Conditions
ThrombocytopeniaIdiopathic Thrombocytopenic Purpura
Interventions
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.

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY