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A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
NCT05662319 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05662319
The ClinicalTrials.gov registry entry for NCT05662319 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05662319 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Ontario, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05662319?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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