Open Label Extension Study of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Condition(s) targeted: Thrombocytopenia; Idiopathic Thrombocytopenic Purpura

Intervention: AMG 531 (Biological)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

The purpose of this study is to determine the safety of AMG 531 as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to AMG 531, and to evaluate changes in patient reported outcomes due to the use of AMG 531. Subjects must have previously completed an AMG 531 ITP study.

Official title: An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Study design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation.

Secondary outcome:

Duration platelet response

The proportion of subjects able to reduce or discontinue their concurrent ITP therapies (corticosteroids, danazol, azathioprine) The change from baseline in patient reported outcomes (PRO)

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must have previously completed an AMG 531 ITP study

- Written informed consent

Exclusion Criteria:

- Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment

in the previous AMG 531 ITP study

- Received any alkylating agents within 4 weeks before screening visit or anticipated

use during the time of the proposed study

- Currently enrolled in or has not yet completed at least 4 weeks since ending device or

drug trial(s) (other than the previous AMG 531 ITP study), or subject is receiving other investigational agent(s) other than AMG 531.

- Not using adequate contraceptive precautions

- Not available for follow-up assessments

- Has any kind of disorder that compromises the ability of the subject to give informed

consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures

Research Site, Herston, Australia

Research Site, Antwerpen, Belgium

Research Site, Leuven, Belgium

Research Site, Brugge, Belgium

Research Site, Brussels, Belgium

Research Site, PARIS CEDEX 15, France

Research Site, Lille, France

Research Site, Pessac Cedex, France

Research Site, Ulm, Germany

Research Site, Essen, Germany

Research Site, Amsterdam, Netherlands

Research Site, Groningen, Netherlands

Research Site, Den Haag, Netherlands

Research Site, Rotterdam, Netherlands

Research Site, Barcelona, Spain

Research Site, Valencia, Spain

Research Site, Madrid, Spain

Research Site, London, United Kingdom

Research Site, Orange, California, United States

Research Site, Berkeley, California, United States

Research Site, Los Angeles, California, United States

Research Site, Duarte, California, United States

Research Site, San Diego, California, United States

Research Site, Manchester, Connecticut, United States

Research Site, Bridgeport, Connecticut, United States

Research Site, Washington, District of Columbia, United States

Research Site, Boynton Beach, Florida, United States

Research Site, Daytona Beach, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Albany, Georgia, United States

Research Site, Marietta, Georgia, United States

Research Site, Peoria, Illinois, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Bethesda, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Bay City, Michigan, United States

Research Site, Southfield, Michigan, United States

Research Site, St. Louis, Missouri, United States

Research Site, Kansas City, Missouri, United States

Research Site, Pamplona, Navarra, Spain

Research Site, Omaha, Nebraska, United States

Research Site, Syracuse, New York, United States

Research Site, New York, New York, United States

Research Site, Durham, North Carolina, United States

Research Site, Cleveland, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Danville, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Montreal, Quebec, Canada

Research Site, Houston, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Arlington, Texas, United States

Research Site, Charlottesville, Virginia, United States

Research Site, Tacoma, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, Huntington, West Virginia, United States

Research Site, La Crosse, Wisconsin, United States

AmgenTrials clinical trials website

Starting date: August 2004
Ending date: December 2009
Last updated: June 5, 2008