clinical trial · NCT03754790
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
Genzyme, a Sanofi Company·phase3·active not recruiting·n = 281
HemophiliaFitusiran
brief 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
started
Jan 9, 2019
primary completion
Nov 5, 2026
completion
Nov 5, 2026
last updated
Dec 17, 2025
detailed description
The estimated total time on the study for a participant is up to 90 months (including screening, treatment period and safety follow up period).
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol