Conditions: Thrombocytopenic Purpura
Keywords: Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia
Allocation: NA | Intervention model: SEQUENTIAL
Enrollment: 16
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.

Detailed description:

Arms:
arm 1: Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.

Interventions: intervention 1: Romiplostim
Intervention descriptions: intervention 1: Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.

Protocol document: