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A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
NCT05911763 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in the US and Japan. Patients will be enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape in each study country. Decision to initiate treatment with commercially available efanesoctocog alfa will be made by the treating physician independently from the decision to include patients in the study. No study medication is provided. The data related to efanesoctocog alfa effectiveness, safety and usage will be collected prospectively during routine visits (expected annual/semi-annual visits) for up to 5 years following enrollment /treatment initiation.
Conditions Studied
Interventions
- DRUG Efanesoctocog Alfa BIVV001
Study Locations (20)
California
- Loma Linda University- Site Number : 8400015 — Loma Linda
- Orthopedic Institute for Children- Site Number : 8400004 — Los Angeles
- The Center for Inherited Blood Disorders- Site Number : 8400001 — Orange
Florida
- William A. Shands Hospital at the University of Florida- Site Number : 8400032 — Gainesville
- Johns Hopkins All Childrens Hospital - Outpatient Care Center - PIN- Site Number : 8400025 — St. Petersburg
Illinois
- Rush University Medical Center -1725 W Harrison St- Site Number : 8400014 — Chicago
- The Bleeding and Clotting Disorders Institute- Site Number : 8400005 — Peoria
Massachusetts
- ~Massachusetts General Hospital- Site Number : 8400017 — Boston
- Dana Farber and Boston Children's Hospital- Site Number : 8400031 — Boston
Minnesota
- M Health Fairview- Masonic Cancer Clinic - Clinics- Site Number : 8400010 — Minneapolis
- Mayo Clinic - PPDS- Site Number : 8400035 — Rochester
Arizona
- Banner MD Anderson Cancer Center- Site Number : 8400008 — Gilbert
Colorado
- University of Colorado Hemophilia and Thrombosis Center- Site Number : 8400019 — Aurora
Indiana
- Indiana Hemophilia and Thrombosis Center- Site Number : 8400013 — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-06-30 |
| Est. Completion | 2030-09-17 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05911763
The ClinicalTrials.gov registry entry for NCT05911763 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, 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 200 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 A appearing as the primary indexed condition, and to 1 intervention — of which Efanesoctocog Alfa BIVV001 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: NCT05911763 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Illinois. 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 NCT05911763 about?
NCT05911763 is a clinical study titled "A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A". This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in the US and Japan. Patients will be enrolled in the study after the in...
What is the current status of trial NCT05911763?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2023-06-30. Estimated completion is 2030-09-17.
What conditions does trial NCT05911763 study?
This clinical trial studies the following conditions: Hemophilia A. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05911763?
The interventions under investigation include: Efanesoctocog Alfa BIVV001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05911763?
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 NCT05911763 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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