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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  

Hemophilia Clinical Trial

Official title:
An Open-label, 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

Clinical Trial 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

Clinical Trial Description

The estimated total time on the study for a participant up to 90 months (including screening, treatment period and safety follow up period). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03754790
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 9, 2019
Completion date November 5, 2026
View Details
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