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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01143038 |
Purpose
The purpose of this study is to describe the number of months with a subject platelet response over a 12 month treatment period and to describe ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Thrombocytopenic Purpura |
Other: AMG 531 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim |
| Estimated Enrollment: | 75 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMG 531
All subjects will receive romiplostim.
|
Other: AMG 531
Romiplostim will be administered weekly by SC injection for 12 months at a starting dose of 1 mcg/kg.
Other Name: Biological: romiplostim
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amgen Call Center | 866-572-6436 |
Show 35 Study Locations| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT01143038 History of Changes |
| Other Study ID Numbers: | 20080435 |
| Study First Received: | June 10, 2010 |
| Last Updated: | November 21, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: Agenzia Italiana del Farmaco Italy: Ministry of Health Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration France: Afssaps - French Health Products Safety Agency |
|
AMGEN ITP |
|
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 |