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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00117143
First received: June 30, 2005
Last updated: May 21, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Safety Study
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:

Drug Information available for: Romiplostim
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117143

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117143     History of Changes
Other Study ID Numbers: 20010218
Study First Received: June 30, 2005
Last Updated: May 21, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013