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
Public ClinicalTrials.gov record NCT07285460. 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
An Open-label, Parallel, Phase 3, Two-arm 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 With or Without Inhibitory Antibodies to Factors VIII or IX
Study identification
- NCT ID
- NCT07285460
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 85 participants
Conditions and interventions
Conditions
Interventions
- Antithrombin concentrate (ATIIIC) Biological
- Clotting factor concentrates (CFC) or bypassing agents (BPA) Biological
- Fitusiran Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 1 Year to 11 Years
- 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
- Dec 17, 2025
- Primary completion
- Aug 3, 2029
- Completion
- Dec 29, 2031
- Last update posted
- May 14, 2026
2025 – 2031
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Luskin Orthopaedic Institute for Children- Site Number : 8400013 | Los Angeles | California | 90007 | Recruiting |
| The Center for Inherited Blood Disorders- Site Number : 8400009 | Orange | California | 92868 | Recruiting |
| Cure 4 The Kids Foundation- Site Number : 8400001 | Las Vegas | Nevada | 89147 | Recruiting |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400008 | Hackensack | New Jersey | 07601 | Recruiting |
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 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07285460, 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 May 14, 2026 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07285460 live on ClinicalTrials.gov.