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A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab

NCT06145373 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-30

No results posted yet for this study

Summary

This is an exploratory, single group, Phase 4, study to assess treatment with fitusiran prophylaxis after switching from emicizumab prophylaxis.

This study aims to evaluate the safety and tolerability of switching to fitusiran after a transition period from the last dose of emicizumab. The study will be conducted in male participants with severe hemophilia A, with or without inhibitors, aged ≥12 years, who were previously receiving emicizumab prophylaxis.

Study details include:

* The study duration will be up to approximately 28 months:

* There will be an approximately 2-month screening period.
* There will be an approximately 2-month period before fitusiran treatment starts (pre-fitusiran treatment period)
* The fitusiran treatment duration will be up to 18-months (fitusiran treatment period)
* The antithrombin (AT) follow-up (FU) period will be approximately 6 months after the last dose of fitusiran (during which the AT activity level will be monitored at approximately monthly intervals following the final fitusiran dose until AT activity levels return to at least 60%).
* The study site visits are scheduled at monthly/ every 2 months intervals of 28 days (4 weeks) / 56 days (8 weeks), respectively, during the fitusiran treatment period.

Conditions

Interventions

DRUG

Fitusiran (SAR439774)

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous (SC) injection

BIOLOGICAL

Clotting factor concentrates (CFC) or bypassing agents (BPA)

Pharmaceutical form: Solution for injection-Route of administration: Intravenous (IV) injection

BIOLOGICAL

Antithrombin concentrate (ATIIIC)

Pharmaceutical form:Solution for injection-Route of administration:Intravenous (IV) injection

BIOLOGICAL

Emicizumab

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-09-19
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06145373 on ClinicalTrials.gov