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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01071954 |
Purpose
This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic subjects with Immune (Idiopathic) Thrombocytopenia Purpura. This study is available to pediatric subjects who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
Biological: Romiplostim |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrompocytopenic Pediatric Subjects With Immune (Ideopathic) Thrombocytopenia Purpura (ITP) |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Singe Arm
Starting Dose of 1µg/kg romiplostim or previous dose administered weekly Individual Subject Dose Adjustment to a Maximum Dose of 10 µg/kg based on platelet count |
Biological: Romiplostim
Starting Dose of 1µg/kg romiplostim or previous dose administered weekly Individual Subject Dose Adjustment to a Maximum Dose of 10 µg/kg based on platelet count Rescue Medications Allowed at Discretion of Investigator Reduction in Concurrent ITP Therapies May Occur when Platelet Count is >50 x 109/L |
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amgen Call Center | 866-572-6436 |
| United States, California | |
| Research Site | Recruiting |
| Orange, California, United States | |
| United States, Nebraska | |
| Research Site | Recruiting |
| Omaha, Nebraska, United States | |
| United States, New York | |
| Research Site | Recruiting |
| New York, New York, United States | |
| United States, Tennessee | |
| Research Site | Recruiting |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Research Site | Recruiting |
| Dallas, Texas, United States | |
| Australia | |
| Research Site | Recruiting |
| Herston, Australia | |
| Spain | |
| Research Site | Recruiting |
| Barcelona, Spain | |
| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT01071954 History of Changes |
| Other Study ID Numbers: | 20090340 |
| Study First Received: | December 17, 2009 |
| Last Updated: | April 1, 2010 |
| Health Authority: | Australia: Therapeutic Goods Administration European Union: European Medicines Agency United States: Food and Drug Administration |
|
Immune thrombocytopenic Purpura Pediatric Thrombocytopenia |
|
Purpura Purpura, Thrombocytopenic Thrombocytopenia Blood Coagulation Disorders Hematologic Diseases Hemorrhage |
Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Blood Platelet Disorders Immune System Diseases |