Conditions: Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura
Keywords: splenectomy platelet AMG 531 thrombopoietin blood disorder bleeding disorder immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura TPO thrombopoietic protein
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief summary:
This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.

Detailed description:

Arms:
arm 1: Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks. arm 2: Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.

Interventions: intervention 1: Medical Standard of Care for ITP intervention 2: Romiplostim
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: