Trial intelligence / Profile preview

Phase 3 single-arm crossover study of fitusiran prophylaxis in severe hemophilia A or B

2022-500221-33-01Phase 3Authorised

Sponsor
Sanofi
Start
Jun 2023
Modality
Chemically Modified siRNA → Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Conjugated siRNA → Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics
Countries
16
01

Overview

Phase 3, open-label, single-arm trial of fitusiran in hemophilia A and hemophilia B (HB), sponsored by Sanofi. Primary endpoint: Annualized Bleeding Rate (ABR) in the fitusiran primary efficacy period. Planned start Jun 2023; status: authorised.

02

Drugs

fitusiran
03

Conditions

hemophilia Ahemophilia B (HB)

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