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NOT YET RECRUITING
NCT07895381

A Study to Describe Patient REal-world FitusiRan ExpeRience

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a real-world, mixed-methods observational study conducted among adolescent (ages 12-17 years) and adult participants diagnosed with hemophilia A or B, with or without Factor VIII (FVIII) or Factor IX (FIX) inhibitors, who are treated with fitusiran. The study includes a prospective longitudinal cohort (Cohort 1) and a cross-sectional cohort (Cohort 2). Data collection includes patient-reported outcomes via online surveys, qualitative interviews conducted via teleconference, and electronic medical record (EMR) review to describe real-world patient experiences, treatment satisfaction, adherence, and clinical management of fitusiran.

Official title: Patient Experience With Fitusiran Prophylaxis in Adolescents and Adults With Hemophilia A or B With or Without Factor VIII or Factor IX Inhibitors in a Real-world Setting

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-10-07

Completion Date

2029-03-02

Last Updated

2026-10-26

Healthy Volunteers

No

Locations (1)

Concentrics Center for Research

Indianapolis, Indiana, United States