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

This study has been completed.

First Received: June 30, 2005 Last Updated: April 16, 2009 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117143

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 I Phase II

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: AMG 531

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
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)

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:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Newland A, Caulier MT, Kappers-Klunne M, Schipperus MR, Lefrere F, Zwaginga JJ, Christal J, Chen CF, Nichol JL. An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. Br J Haematol. 2006 Nov;135(4):547-53.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010218
Study First Received:	June 30, 2005
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00117143 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Amgen:

Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
ITP
Thrombocytopenia

Study placed in the following topic categories:

Purpura
Thrombocytopathy
Signs and Symptoms
Thrombocytopenia
Thrombocytopenic Purpura, Autoimmune
Hematologic Diseases

Blood Platelet Disorders
Blood Coagulation Disorders
Purpura, Thrombocytopenic, Idiopathic
Hemostatic Disorders
Purpura, Thrombocytopenic

Additional relevant MeSH terms:

Purpura
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Immune System Diseases

Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Purpura, Thrombocytopenic

ClinicalTrials.gov processed this record on May 07, 2009