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NCT04644575 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
A Phase 3 study of Hemophilia A, sponsored by Bioverativ, a Sanofi company.
- Active
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
- 20
- Study locations
NCT04644575: Active Phase 3 study of Hemophilia A, sponsored by Bioverativ, a Sanofi company.
NCT04644575 is a Phase 3 study of Hemophilia A that is active but no longer recruiting, run by Bioverativ, a Sanofi company. The registered enrollment target is 261 participants, above the 85-participant average among 42 other Hemophilia A trials with a reported enrollment target (207% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04644575, a Phase 3 study of Hemophilia A, is active but no longer recruiting, sponsored by Bioverativ, a Sanofi company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: \- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: * To evaluate the efficacy of BIVV001 as a prophylaxis treatment. * To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. * To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. * To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. * To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B). * To evaluate the efficacy of BIVV001 for perioperative management
Primary Outcome
The number of participants with the occurrence of inhibitor development (neuatralizing antibodies detected against factor VIII \[FVIII\]) as determined via the Nijmegen modified Bethesda assay.
Conditions Studied
Interventions
- DRUG efanesoctocog alfa (BIVV001)
Study Locations (20)
California
- Orthopaedic Institute for Children Site Number : 8400003 - Los Angeles
- Children's Hospital Los Angeles Site Number : 8400009 - Los Angeles
- University of California San Diego Site Number : 8400007 - San Diego
Michigan
- University of Michigan Medical Center Site Number : 8400006 - Ann Arbor
- Michigan State University School Of Med Site Number : 8400002 - East Lansing
Ohio
- Cincinnati Children's Hospital Medical Center Site Number : 8400012 - Cincinnati
- Children's Research Institute Site Number : 8400013 - Columbus
Florida
- University of Florida Health Site Number : 8400008 - Gainesville
Georgia
- Children's Healthcare of Atlanta Site Number : 8400016 - Atlanta
Illinois
- Rush University Medical Center Site Number : 8400010 - Chicago
Iowa
- Children's Hospital Of Iowa Site Number : 8400011 - Iowa City
Nevada
- Hemostasis and Thrombosis Center of Nevada Site Number : 8400001 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2027-01-15 |
| Phase | Phase 3 |
What the registry record for NCT04644575 still lists
NCT04644575 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, above the 85-participant average among 42 other Hemophilia A trials with a reported enrollment target (207% higher).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which efanesoctocog alfa (BIVV001) is the first listed.
NCT04644575 names 20 study sites across 16 states, led by California, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT04644575 about?
NCT04644575 is a clinical study titled "Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A". Primary Objective: \- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: * To evaluate the efficacy of BIVV001 as a prophylaxis treatment. * To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. * To evaluate BIV...
What is the current status of trial NCT04644575?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2021-02-23. Estimated completion is 2027-01-15.
What conditions does trial NCT04644575 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT04644575?
The interventions under investigation include: efanesoctocog alfa (BIVV001) (DRUG).
Who is sponsoring clinical trial NCT04644575?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04644575 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
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 NCT04644575's enrollment target sits among peer trials
261 3rd of 42 higher than 40 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A 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.
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