Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX (ATLAS-OLE)

  • STATUS
    Not Recruiting
  • End date
    Oct 19, 2026
  • participants needed
    355
  • sponsor
    Genzyme, a Sanofi Company
Updated on 10 June 2022

Summary

Primary Objective:

To characterize the long-term safety and tolerability of fitusiran

Secondary Objectives:

  • To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of:
  • Bleeding episodes
  • Spontaneous bleeding episodes
  • Joint bleeding episodes
  • To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age

Description

The estimated total time on study for each participant is up to 56 months which consists of a screening period of up to 60 days, an open label treatment period of up to 48 months and a follow up period of up to 6-month after the last dose of fitusiran. The duration of the treatment period and overall that of study participation, may exceed the intervals stated above for patient enrolled in the lower-dose cohort, to ensure a minimum of 18-month administration at this dosing regimen

Details
Condition Hemophilia
Treatment fitusiran
Clinical Study IdentifierNCT03754790
SponsorGenzyme, a Sanofi Company
Last Modified on10 June 2022

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