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

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 30, 2005
Last updated: May 21, 2009
Last verified: May 2009
The purpose of this study is to assess the safety, tolerability, and utility of AMG 531 unit dosing (µg) in thrombocytopenic subjects with ITP.

Condition Intervention Phase
Thrombocytopenic Purpura
Drug: AMG 531
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Unit Dose-Finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety as measured by the incidence and severity of all adverse events and the evaluation of antibody status.

Secondary Outcome Measures:
  • Proportion of subjects achieving targeted platelet level (doubling of baseline platelet count and within 50 x 10^9/L to 450 x 10^9/L)
  • Proportion of subjects achieving specified increases and peak counts
  • Peak count and time to peak
  • Change from baseline
  • Duration within targeted range


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Greater than or equal to 3 months history if 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
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Please refer to this study by its identifier: NCT00117143

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00117143     History of Changes
Other Study ID Numbers: 20010218
Study First Received: June 30, 2005
Last Updated: May 21, 2009

Keywords provided by Amgen:
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases processed this record on April 26, 2017