A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
Public ClinicalTrials.gov record NCT05662319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05662319
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 91 participants
Conditions and interventions
Conditions
Interventions
- Fitusiran Drug
- Clotting factor concentrates (CFC) or bypassing agents (BPA) Drug
- Antithrombin concentrate (ATIIIC) Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1, 2023 (Actual)
- Primary completion
- Mar 25, 2027 (Estimated)
- Completion
- Jan 25, 2029 (Estimated)
- Last update posted
- Feb 4, 2026
2023 – 2029
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Inherited Blood Disorders (CIBD) Site Number : 8400012 | Orange | California | 92868-4306 | — |
| M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400016 | Minneapolis | Minnesota | 55454 | — |
| Hackensack University Site Number : 8400009 | Hackensack | New Jersey | 07601 | — |
| Northwell Health Hemostasis and Thrombosis Center Site Number : 8400015 | New Hyde Park | New York | 11040 | — |
| University Hospitals of Cleveland Site Number : 8400001 | Cleveland | Ohio | 44106 | — |
| UPMC Children's Hospital of Pittsburgh-4401 Penn Ave Site Number : 8400017 | Pittsburgh | Pennsylvania | 15224-1334 | — |
| Children's Medical Center Dallas- Site Number : 8400018 | Dallas | Texas | 75235 | — |
| Gulf States Hemophilia and Thrombophilia Center- Site Number : 8400002 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05662319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05662319 live on ClinicalTrials.gov.