Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Thrombocytopenic Thrombocytopenia ITP
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 45
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.

Detailed description:

Arms:
arm 1: Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 2: Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 3: Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. arm 4: Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 5: Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 6: Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. arm 7: Participants received placebo subcutaneously once a week for 6 weeks. arm 8: Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks. arm 9: Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks. arm 10: Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks.

Interventions: intervention 1: Romiplostim intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol document: