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NCT06145373 · ClinicalTrials.gov registry record · Phase 4
A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
A Phase 4 study of Hemophilia A, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06145373 is a Phase 4 study of Hemophilia A that is actively recruiting participants, run by Sanofi. The registered enrollment target is 20 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06145373, a Phase 4 study of Hemophilia A, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- BIOLOGICAL Clotting factor concentrates (CFC) or bypassing agents (BPA)
- BIOLOGICAL Antithrombin concentrate (ATIIIC)
- DRUG Fitusiran (SAR439774)
- BIOLOGICAL Emicizumab
Study Locations (2)
California
- Children's Hospital Los Angeles- Site Number : 8400005 - Los Angeles
Podlaskie
- Investigational Site Number : 1580001 - Taipei
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06145373
The ClinicalTrials.gov registry entry for NCT06145373 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (78% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 4 interventions - of which Clotting factor concentrates (CFC) or bypassing agents (BPA) is the first listed.
NCT06145373 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Podlaskie.
Frequently Asked Questions
What is clinical trial NCT06145373 about?
NCT06145373 is a clinical study titled "A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab". 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 wi...
What is the current status of trial NCT06145373?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-03-01. Estimated completion is 2029-11-30.
What conditions does trial NCT06145373 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT06145373?
The interventions under investigation include: Clotting factor concentrates (CFC) or bypassing agents (BPA) (BIOLOGICAL), Antithrombin concentrate (ATIIIC) (BIOLOGICAL), Fitusiran (SAR439774) (DRUG), Emicizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06145373?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06145373 being conducted?
This trial has 2 study locations across California, Podlaskie. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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