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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117143
First Posted: July 4, 2005
Last Update Posted: May 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117143


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117143     History of Changes
Other Study ID Numbers: 20010218
First Submitted: June 30, 2005
First Posted: July 4, 2005
Last Update Posted: May 22, 2009
Last Verified: May 2009

Keywords provided by Amgen:
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
ITP
Thrombocytopenia

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases