Safety Study of AMG 531 in Japanese Subjects With ITP

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Treatments: Drug: Romiplostim (AMG-531)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00305435

20050162

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Full description

The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Enrollment: 12 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

romiplostim (AMG-531)

Experimental group

Treatment:

Drug: Romiplostim (AMG-531)