Safety Study of AMG 531 in Japanese Subjects With ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

NCT00111475

Idiopathic Thrombocytopenic Purpura

COMPLETED PHASE2

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects

NCT00515203

Idiopathic Thrombocytopenic Purpura Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

COMPLETED PHASE1/PHASE2

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

NCT00117143

Thrombocytopenic Purpura

COMPLETED PHASE1/PHASE2

Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

NCT00440037

Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

COMPLETED PHASE2/PHASE3

P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

NCT00603642

Idiopathic Thrombocytopenic Purpura

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

romiplostim (AMG-531)

Group Type EXPERIMENTAL

Romiplostim (AMG-531)

Intervention Type DRUG

Romiplostim (AMG-531)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romiplostim (AMG-531)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No