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

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00116688

Purpose

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.

Condition	Intervention	Phase
Thrombocytopenia Idiopathic Thrombocytopenic Purpura	Biological: AMG 531	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia MYH9-related disorder thrombotic thrombocytopenic purpura

Drug Information available for: AMG 531

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Adverse Events [ Time Frame: Duration of treatment plus 8 weeks (up to 285 weeks) ] [ Designated as safety issue: Yes ]
One or more occurrences of one or more adverse events within the participant up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.

Secondary Outcome Measures:

Platelet Response [ Time Frame: Duration of treatment (up to 277 weeks) ] [ Designated as safety issue: No ]
Platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications
Reduction or Discontinuation of Concurrent ITP Therapies [ Time Frame: Duration of treatment (up to 277 weeks) ] [ Designated as safety issue: No ]
Reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine)

Enrollment:	313
Study Start Date:	August 2004
Study Completion Date:	July 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AMG 531 Active investigational product	Biological: AMG 531 Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 10mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116688

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

Publications:

Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009 Mar 5;113(10):2161-71. Epub 2008 Nov 3.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. Epub 2009 Aug 11.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00116688 History of Changes
Other Study ID Numbers:	20030213
Study First Received:	June 30, 2005
Results First Received:	March 4, 2011
Last Updated:	March 4, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Directorate-General for Medicinal Products; Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: FPS of Public Health, Food Chain Security and Environment; Belgium: Pharmaceutical Inspectorate; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement; Canada: Health Canada; Canada: Health Products and Food Branch; Canada: Institutional Review Board; Czech Republic: State Institute for Drug Control; Czech Republic: Statni ustav pro kontrolu leciv; EU: CHMP; European Union: European Medicines Agency; France and Sweden: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: CCPPRB Central Ethics Committee; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Italy: Local Ethics Committees; Italy: Ministry of Health; Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Austria: Secretariat of Health; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Switzerland: Agency for Therapeutic Products; Switzerland: Local Ethics Committee; Switzerland: Swissmedic (Swiss Agency for Therapeutic Products); United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information; Austria: Bundesamt fur Sicherheit im Gesundheitswesen; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Austria: Central Ethics Committee; Austria: Competant Authority; Austria: Federal Ministry for Health and Women

Keywords provided by Amgen:

Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenic

Additional relevant MeSH terms:

Purpura
Purpura, Thrombocytopenic
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes

Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on February 12, 2012