A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura
This study is currently recruiting participants.
Verified April 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01071954
First received: December 17, 2009
Last updated: April 23, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 17, 2009 | ||||
| Last Updated Date | April 23, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01071954 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura | ||||
| Official Title ICMJE | An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Single 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
Intervention: Biological: Romiplostim |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2017 | ||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Australia, Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01071954 | ||||
| Other Study ID Numbers ICMJE | 20090340 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Amgen | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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