RecruitingPhase 3NCT06716814

Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa

A Multinational, Prospective, Open-label, Roll-over Study (LIBERTY) to Provide Post-trial Access to Treatment for Patients With Haemophilia A Who Have Completed a Previous Trial With Efanesoctocog Alfa


Sponsor

Swedish Orphan Biovitrum

Enrollment

104 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multinational, prospective, open-label, roll-over study in patients with haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), PK comparison study (Sobi.BIVV001-003) or SHINE study (Sobi.BIVV001-004). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient's respective country (or until March 2027, whichever comes first). The study starts with the Baseline Visit, which will be done in connection to the end of treatment at the EoT/EoS visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.


Eligibility

Sex: MALEMin Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Efanesoctocog alfa for people with haemophilia a (moderate or severe). The study is currently recruiting participants at 21 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEfanesoctocog alfa

Treatment starts when the patient completes the parent study and continues until efanesoctocog alfa is commercially available in each patient's respective country, or until March 2027, whichever comes first.


Locations(21)

Sobi Investigational Site

Plovdiv, Bulgaria

Sobi Investigational Site

Sofia, Bulgaria

Sobi Investigational Site

Brest, France

Sobi Investigational Site

Bron, France

Sobi Investigational Site

Lille, France

Sobi Investigational Site

Strasbourg, France

Sobi Investigational Site

Athens, Greece

Sobi Investigational Site

Catanzaro, Italy

Sobi Investigational Site

Florence, Italy

Sobi Investigational Site

Milan, Italy

Sobi Investigational Site

Naples, Italy

Sobi Investigational Site

Parma, Italy

Sobi Investigational Site

Rome, Italy

Sobi Investigational Site

Rozzano, Italy

Sobi Investigational Site

Vicenza, Italy

Sobi Investigational Site

Oslo, Norway

Sobi Investigational Site

A Coruña, Spain

Sobi Investigational Site

Zaragoza, Spain

Sobi Investigational Site

Gothenburg, Sweden

Sobi Investigational Site

Lund, Sweden

Sobi Investigational Site

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

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NCT06716814