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

Last updated: January 26, 2026
Sponsor: Swedish Orphan Biovitrum
Overall Status: Active - Recruiting

Phase

3

Condition

Blood Clots

Hemophilia

Treatment

Efanesoctocog alfa

Clinical Study ID

NCT06716814
Sobi.BIVV001-002
2023-506537-29-00
  • Ages > 6
  • Male

Study Summary

This is a multinational, prospective, open-label, roll-over study in patients with severe 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), or PK comparison study (Sobi.BIVV001-003). 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 Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Capable of giving signed informed consent. Parents or legally designatedrepresentatives' consent is required for patients who are below 18 years of age orunable to give consent. Patients who are below 18 years of age may provide assent inaddition to the parents'/legally designated representatives' consent, ifappropriate.

  • Must have completed one of the required parent studies: Sobi.BIVV001-001,Sobi.BIVV001-003, or LTS16294, and be receiving a clinical benefit from theefanesoctocog alfa treatment, as judged by the Investigator.

  • Willingness and ability of patient or their parent or legally designatedrepresentative to complete training in the use of the study patient diary and tocomplete the diary throughout the study.

Exclusion

Exclusion Criteria:

  • Positive inhibitor result (assessed by central laboratory), defined as ≥0.6 Bethesdaunits (BU)/mL, at Baseline Visit.

  • Ongoing or planned participation in any interventional clinical study at BaselineVisit.

  • Patient not suitable for participation, whatever the reason, as judged by theInvestigator, including medical or clinical conditions, or patients potentially atrisk of noncompliance to study procedures.

Study Design

Total Participants: 104
Treatment Group(s): 1
Primary Treatment: Efanesoctocog alfa
Phase: 3
Study Start date:
March 06, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Sobi Investigational Site

    Plovdiv,
    Bulgaria

    Site Not Available

  • Sobi Investigational Site

    Plovdiv 728193,
    Bulgaria

    Active - Recruiting

  • Sobi Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • Sobi Investigational Site

    Sofia 727011,
    Bulgaria

    Active - Recruiting

  • Sobi Investigational Site

    Bordeaux,
    France

    Site Not Available

  • Sobi Investigational Site

    Bordeaux 3031582,
    France

    Site Not Available

  • Sobi Investigational Site

    Brest,
    France

    Site Not Available

  • Sobi Investigational Site

    Brest 3030300,
    France

    Site Not Available

  • Sobi Investigational Site

    Bron,
    France

    Site Not Available

  • Sobi Investigational Site

    Bron 3029931,
    France

    Site Not Available

  • Sobi Investigational Site

    Le Kremlin-Bicetre,
    France

    Site Not Available

  • Sobi Investigational Site

    Le Kremlin-Bicêtre 3003737,
    France

    Site Not Available

  • Sobi Investigational Site

    Lille,
    France

    Site Not Available

  • Sobi Investigational Site

    Lille 2998324,
    France

    Site Not Available

  • Sobi Investigational Site

    Marseille,
    France

    Site Not Available

  • Sobi Investigational Site

    Marseille 2995469,
    France

    Site Not Available

  • Sobi Investigational Site

    Strasbourg,
    France

    Site Not Available

  • Sobi Investigational Site

    Strasbourg 2973783,
    France

    Site Not Available

  • Sobi Investigational Site

    Athens,
    Greece

    Site Not Available

  • Sobi Investigational Site

    Athens 264371,
    Greece

    Active - Recruiting

  • Sobi Investigational Site

    Catanzaro,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Catanzaro 2525059,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Florence,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Florence 3176959,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Milan,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Milan 6951411,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Milano,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Naples,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Naples 3172394,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Parma,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Parma 3171457,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Rome,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Rome 3169070,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Rozzano 3168837,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Vicenza,
    Italy

    Site Not Available

  • Sobi Investigational Site

    Vicenza 3164419,
    Italy

    Active - Recruiting

  • Sobi Investigational Site

    Oslo 3143244,
    Norway

    Active - Recruiting

  • Sobi Investigational Site

    A Coruña,
    Spain

    Site Not Available

  • Sobi Investigational Site

    A Coruña 3119841,
    Spain

    Site Not Available

  • Sobi Investigational Site

    Valencia,
    Spain

    Site Not Available

  • Sobi Investigational Site

    Zaragoza,
    Spain

    Site Not Available

  • Sobi Investigational Site

    Zaragoza 3104324,
    Spain

    Site Not Available

  • Sobi Investigational Site

    Lund 2693678,
    Sweden

    Active - Recruiting

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