Open Label Extension Study of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00116688
First received: June 30, 2005
Last updated: March 4, 2011
Last verified: March 2011
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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 3 |
| 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:
thrombotic thrombocytopenic purpura
Drug Information available for:
Romiplostim
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 More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 May 23, 2013