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NCT05911763 · ClinicalTrials.gov registry record

A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A

A clinical trial of Hemophilia A, sponsored by Sanofi.

Active
Registry status
200
Enrollment target
20
Study locations

NCT05911763 is a study of Hemophilia A that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 200 participants, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT05911763, a study of Hemophilia A, is active but no longer recruiting, sponsored by Sanofi.

ACTIVE NOT RECRUITING
Registry status
200 participants
Enrollment target
20
Study locations

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

FieldValue
Enrollment Target 200 participants
Start Date 2023-06-30
Est. Completion 2030-09-17

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT05911763

The ClinicalTrials.gov registry entry for NCT05911763 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (130% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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.

NCT05911763 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Illinois.

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.

What interventions are being tested in trial NCT05911763?

The interventions under investigation include: Efanesoctocog Alfa BIVV001 (DRUG).

Who is sponsoring clinical trial NCT05911763?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.