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Hemophilia B

A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B
NCT01361126 | PHASE 1 | INTERVENTIONAL

This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. The study consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5 month treatment period. Subjects will receive weekly routine prophylactic therapy and on-demand treatment for bleeding episodes. In addition, subjects who are not on routine factor replacement therapy prior to the study will receive only on-demand treatment for bleeding episodes.

Trial Information
2 Sites
17 Participants
Recruiting
12 Years to 65 Years

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Study Site
Sofia,Bulgaria
Study Site
Tel Aviv,Israel

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov