200 Participants Needed

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

Recruiting at 70 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free number for US & Canada)
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Sanofi
Must be taking: Efanesoctocog alfa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial observes the real-world use of efanesoctocog alfa in patients with hemophilia A in the US and Japan. Efanesoctocog alfa helps blood clot properly by replacing a missing protein. The study will collect data on its effectiveness and safety during routine medical visits over several years.

Research Team

CS

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Inclusion Criteria

Have a diagnosis of hemophilia A
Patients starting efanesoctocog alfa treatment as per standard of care no more than one month prior to the enrollment date, for either on demand or prophylaxis. Patients starting efanesoctocog alfa treatment for a surgery event may also be enrolled only if the treatment is prescribed at enrollment.
Physician's decision to treat the patient with efanesoctocog alfa is made prior to and independently of participation in the study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape

Up to 5 years
Annual/semi-annual visits

Follow-up

Participants are monitored for safety and effectiveness of efanesoctocog alfa

Up to 5 years
Annual/semi-annual visits

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort B (On-Demand treatment)Experimental Treatment1 Intervention
Participants receiving on-demand treatment with efanesoctocog alfa who fulfil the overall study inclusion/exclusion criteria
Group II: Cohort A (Prophylactic treatment)Experimental Treatment1 Intervention
All participants on efanesoctocog alfa prophylactic treatment fulfilling the overall study inclusion/exclusion criteria. The prophylactic cohort will include the following sub-cohorts: Sub-cohort A1 (Joint imaging): Participants with severe hemophilia A and joint imaging by Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) or Joint Tissue Activity and Damage Exam (JADE) protocol performed within 6 months of initiating treatment with efanesoctocog alfa or within 3 months after initiating treatment with efanesoctocog alfa available. Sub-cohort A2 (Children with no prior joint damage):Participants with severe hemophilia A who have no prior joint damage

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

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