A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
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ClinicalTrials.gov Identifier: NCT01496274 |
Recruitment Status :
Completed
First Posted : December 21, 2011
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
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Sponsor:
CSL Behring
Information provided by (Responsible Party):
CSL Behring
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Tracking Information | ||||
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First Submitted Date ICMJE | December 19, 2011 | |||
First Posted Date ICMJE | December 21, 2011 | |||
Results First Submitted Date ICMJE | April 3, 2016 | |||
Results First Posted Date ICMJE | May 9, 2016 | |||
Last Update Posted Date | May 9, 2016 | |||
Study Start Date ICMJE | February 2012 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B | |||
Official Title ICMJE | A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B | |||
Brief Summary | This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hemophilia B | |||
Intervention ICMJE | Biological: rIX-FP
Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration
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Study Arms ICMJE |
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Publications * | Santagostino E, Martinowitz U, Lissitchkov T, Pan-Petesch B, Hanabusa H, Oldenburg J, Boggio L, Negrier C, Pabinger I, von Depka Prondzinski M, Altisent C, Castaman G, Yamamoto K, Álvarez-Roman MT, Voigt C, Blackman N, Jacobs I; PROLONG-9FP Investigators Study Group. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016 Apr 7;127(14):1761-9. doi: 10.1182/blood-2015-09-669234. Epub 2016 Jan 11. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
63 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 65 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Bulgaria, France, Germany, Israel, Italy, Japan, Russian Federation, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01496274 | |||
Other Study ID Numbers ICMJE | CSL654_3001 2011-002415-28 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | CSL Behring | |||
Study Sponsor ICMJE | CSL Behring | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | CSL Behring | |||
Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |