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NCT03974113 · ClinicalTrials.gov registry record · Phase 3
Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B
A Phase 3 study of Hemophilia, sponsored by Genzyme, a Sanofi Company.
- Active
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
- 16
- Study locations
NCT03974113 is a Phase 3 study of Hemophilia that is active but no longer recruiting, run by Genzyme, a Sanofi Company. The registered enrollment target is 32 participants, below the 407-participant average among 9 other Hemophilia trials with a reported enrollment target (92% lower). The trial reports 16 study locations across 7 states.
The verdict
NCT03974113, a Phase 3 study of Hemophilia, is active but no longer recruiting, sponsored by Genzyme, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
- 16
- Study locations
Study Summary
Primary Objective: \- To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to \<12 years of age) with severe hemophilia A or B Secondary Objectives: * To characterize the safety and tolerability * To determine fitusiran plasma concentrations at selected time points
Conditions Studied
Interventions
- DRUG Fitusiran
Study Locations (16)
Other
- Investigational Site Number : 3560006 - Bangalore
- Investigational Site Number : 3560002 - Mumbai
- Investigational Site Number : 3560001 - Pune-411011
- Investigational Site Number : 3560004 - Vellore
- Investigational Site Number : 3800002 - Florence
- Investigational Site Number : 3800001 - Milan
- Investigational Site Number : 7920001 - Adana
- Investigational Site Number : 7920002 - Istanbul
- Investigational Site Number : 7920003 - Izmir
Ontario
- Investigational Site Number : 1240001 - Hamilton
- Investigational Site Number : 1240002 - Ottawa
California
- Children's Hospital Los Angeles Site Number : 8400002 - Los Angeles
New Jersey
- Hackensack University Medical Center- Site Number : 8400008 - Hackensack
Ohio
- University Hospitals of Cleveland- Site Number : 8400007 - Cleveland
Pennsylvania
- Penn State Milton S. Hershey Medical Center- Site Number : 8400006 - Hershey
Madrid, Comunidad de
- Investigational Site Number : 7240002 - Madrid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2026-12-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03974113
The ClinicalTrials.gov registry entry for NCT03974113 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 9 other Hemophilia trials with a reported enrollment target (92% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia appearing as the primary indexed condition, and to 1 intervention - of which Fitusiran is the first listed.
NCT03974113 reports 16 study locations spanning 7 distinct geographic areas - top geographies include Other, Ontario, California.
Frequently Asked Questions
What is clinical trial NCT03974113 about?
NCT03974113 is a clinical study titled "Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B". Primary Objective: \- To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to \<12 years of age) with severe hemophilia A or B Secondary Objectives: * To characterize the safety and tolerability * To determine fitusiran plasma concentrations at ...
What is the current status of trial NCT03974113?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2020-01-28. Estimated completion is 2026-12-15.
What conditions does trial NCT03974113 study?
This clinical trial studies the following conditions: Hemophilia.
What interventions are being tested in trial NCT03974113?
The interventions under investigation include: Fitusiran (DRUG).
Who is sponsoring clinical trial NCT03974113?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03974113 being conducted?
This trial has 16 study locations across California, New Jersey, Ohio, Pennsylvania, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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