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Hemophilia A With Inhibitors

Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors
NCT02484638 | PHASE 2 | INTERVENTIONAL

The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2 (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the best efficacy and safety in stopping acute bleeding events (this dose will be called the "population best dose"). The purpose of the final Part 3 (Repeated-dose part) is to confirm the efficacy and safety of the "population best dose" identified in Part 2. In Parts 2 and 3, subje

Trial Information
10 Sites
25 Participants
Recruiting
12 Years to 65 Years

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Tbilisi,Georgia,0179
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Milano,Italy,20122
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Kuala Lumpur,Malaysia,50400
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Kemerovo,Russian Federation,650061
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Johannesburg,South Africa,2193
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Madrid,Spain,28046
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Bangkok,Thailand,10400
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Khon Kaen,Thailand,40002
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Lviv,Ukraine,79044
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London,United Kingdom,NW32QG

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov