Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Amgen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Thrombocytopenic Purpura

Treatments: Drug: Romiplostim

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117143

20010218

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP
• 2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy)
• Ability to give informed consent

Exclusion criteria

• Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Romiplostim

Experimental group

Description:

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.

Treatment:

Drug: Romiplostim