Overview

A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis

Status:
Active, not recruiting

Trial end date:
2022-09-01

Target enrollment:

Participant gender:

Summary

Primary Objective: To characterize the frequency of bleeding episodes while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor or bypassing agent (BPA) prophylaxis Secondary Objectives: - To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: - the frequency of spontaneous bleeding episodes - the frequency of joint bleeding episodes - health related quality of life (HRQOL) in patients ≥17 years of age - To characterize the frequency of bleeding episodes during the onset and treatment periods in patients receiving fitusiran - To characterize the safety and tolerability of fitusiran - Annualized weight-adjusted consumption of factor/BPA

Phase:

Phase 3

Details

Lead Sponsor:

Genzyme, a Sanofi Company

Treatments:

Factor VIII