A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B

Recruiting Phase 3 Interventional Study
Hemophilia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
1 – 11
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
85 (estimated)
Sponsor
Sanofi · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
This is a parallel, Phase 3, two-arm, open-label study to evaluate the efficacy and safety of treatment with fitusiran prophylaxis administered to male pediatric participants (aged 1 to \<12 years) who have severe hemophilia A or B, with or without inhibitory antibodies to FVIII or FIX. Number of participants: Approximately 85 participants will be enrolled into the study: * Approximately 60 fit…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: Participants not previously exposed to fitusiran are eligible to be included in the study only if all of the following criteria apply: * Participant must be 1 to \<12 years of age at the time of enrollment. * Participants must have severe hemophilia A or B (FVIII \<1% or FIX ≤2…
Contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

Contact-US@sanofi.com

CONTACT