An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B

It is anticipated that patients in this study will receive treatment with open label fitusiran for approximately 6 years or until fitusiran becomes commercially available, whichever occurs first.

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

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

An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B

Recruitment

Summary

Participation Requirements

Description

Tracking Information