A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hemophilia A
- Hemophilia B
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Only males
Description
The duration of treatment with fitusiran is 9 months. The estimated total time on study, inclusive of Screening, for each patient is up to 11 months for all patients who enroll in the extension study and patients in the on-demand arm who do not enroll in the extension study. The estimated total time...
The duration of treatment with fitusiran is 9 months. The estimated total time on study, inclusive of Screening, for each patient is up to 11 months for all patients who enroll in the extension study and patients in the on-demand arm who do not enroll in the extension study. The estimated total time on the study may be up to 17 months in fitusiran treatment arm patients who do not enroll in the extension study due to the requirement for an additional 6 months of follow-up monitoring for antithrombin levels.
Tracking Information
- NCT #
- NCT03417102
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations, MD Sanofi
Get Well Soon