At a glance
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An Open-label Extension Study of Subcutaneously Administered Fitusiran in Patients With Moderate or Severe Hemophilia A or B Who Have Participated in a Previous Clinical Study With Fitusiran
In Brief
A Phase 2 clinical trial evaluating Fitusiran (SAR439774) for Hemophilia A and Hemophilia B. Completed, enrolled 34 participants across 12 sites in 5 countries.
Detailed Summary
Primary Objective: To evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia A or B Secondary Objectives: * To investigate the long-term efficacy of fitusiran * To characterize the safety and efficacy of concomitantly administered Factor VIII (FVIII), Factor IX (FIX) or bypassing agents (BPA) and fitusiran for treatment of bleeding episodes * To assess changes in health-related quality of life (QOL) over time * To characterize antithrombin (AT) reduction and thrombin generation (TG) increase * To characterize the pharmacokinetics (PK) of fitusiran
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection Route of administration : subcutaneous (sc)