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NCT05662319 · ClinicalTrials.gov registry record · Phase 3
A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
A Phase 3 study of Hemophilia, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
- 20
- Study locations
NCT05662319: Active Phase 3 study of Hemophilia, sponsored by Sanofi.
NCT05662319 is a Phase 3 study of Hemophilia that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 91 participants, below the 400-participant average among 9 other Hemophilia trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05662319, a Phase 3 study of Hemophilia, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia. The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment. The total study duration will be up to approximately 50 months (200 weeks, 1 study month is equivalent to 4 weeks) and will include: * A screening period up to approximately 60 days, * A standard of care (SOC) period of approximately 6 study months (24 weeks), * A fitusiran treatment period of approximately 36 study months (144 weeks), * An antithrombin (AT) follow-up period of approximately 6 study months (24 weeks) but may be shorter or longer depending on individual participants AT recovery. The frequency for telephone visits will be approximately every 2 weeks. For site visits the frequency will be approximately every 8 weeks during the SOC period and approximately every 4 weeks during the fitusiran treatment period. If applicable and if allowed by local regulation, home and/or remote visits may be conducted during the study
Primary Outcome
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Conditions Studied
Interventions
- DRUG Fitusiran
- DRUG Clotting factor concentrates (CFC) or bypassing agents (BPA)
- DRUG Antithrombin concentrate (ATIIIC)
Study Locations (20)
Other
- Investigational Site Number : 1560003 - Beijing
- Investigational Site Number : 1560001 - Guangzhou
- Investigational Site Number : 1560002 - Jinan
- Investigational Site Number : 2500003 - Le Kremlin-Bicêtre
- Investigational Site Number : 2500002 - Lille
- Investigational Site Number : 2500001 - Paris
- Investigational Site Number : 2760001 - Berlin
- Investigational Site Number : 2760002 - Hamburg
- Investigational Site Number : 3000001 - Athens
Ontario
- Investigational Site Number : 1240001 - Hamilton
- Investigational Site Number : 1240002 - Hamilton
- Investigational Site Number : 1240004 - Toronto
Texas
- Children's Medical Center Dallas- Site Number : 8400018 - Dallas
- Gulf States Hemophilia and Thrombophilia Center- Site Number : 8400002 - Houston
California
- Center for Inherited Blood Disorders (CIBD) Site Number : 8400012 - Orange
Minnesota
- M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400016 - Minneapolis
New Jersey
- Hackensack University Site Number : 8400009 - Hackensack
New York
- Northwell Health Hemostasis and Thrombosis Center Site Number : 8400015 - New Hyde Park
Ohio
- University Hospitals of Cleveland Site Number : 8400001 - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2029-01-25 |
| Phase | Phase 3 |
What the registry record for NCT05662319 still lists
NCT05662319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 400-participant average among 9 other Hemophilia trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Hemophilia appearing as the primary indexed condition, and to 3 interventions - of which Fitusiran is the first listed.
NCT05662319 names 20 study sites across 9 states, led by Other, Ontario, Texas.
Frequently Asked Questions
What is clinical trial NCT05662319 about?
NCT05662319 is a clinical study titled "A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia". This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia. The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A ...
What is the current status of trial NCT05662319?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2023-02-01. Estimated completion is 2029-01-25.
What conditions does trial NCT05662319 study?
This clinical trial studies the following conditions: Hemophilia.
What interventions are being tested in trial NCT05662319?
The interventions under investigation include: Fitusiran (DRUG), Clotting factor concentrates (CFC) or bypassing agents (BPA) (DRUG), Antithrombin concentrate (ATIIIC) (DRUG).
Who is sponsoring clinical trial NCT05662319?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05662319 being conducted?
This trial has 20 study locations across California, Minnesota, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05662319's enrollment target sits among peer trials
91 3rd of 9 higher than 7 of 9 other Hemophilia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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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
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The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
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