Conditions: Idiopathic Thrombocytopenic Purpura Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Keywords: Immune (Idiopathic) Thrombocytopenic Purpura Pediatric Idiopathic Thrombocytopenic Purpura
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an effective dose and schedule, will be well tolerated treatment for thrombocytopenia among pediatric subjects with chronic ITP.

Detailed description:

Arms:
arm 1: 5 thrombocytopenic (as defined per protocol) subjects arm 2: 15 thrombocytopenic (as defined per protocol) subjects

Interventions: intervention 1: Placebo intervention 2: AMG 531
Intervention descriptions: intervention 1: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. intervention 2: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.

Protocol document: