Phase
Condition
Hemophilia
Treatment
Efanesoctocog alfa
Clinical Study ID
Ages > 6 Male
Study Summary
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
Connect with a study center
Sobi Investigational Site
Plovdiv,
BulgariaSite Not Available
Sobi Investigational Site
Sofia,
BulgariaSite Not Available
Sobi Investigational Site
Bordeaux,
FranceSite Not Available
Sobi Investigational Site
Brest,
FranceSite Not Available
Sobi Investigational Site
Bron,
FranceSite Not Available
Sobi Investigational Site
Le Kremlin-Bicetre,
FranceSite Not Available
Sobi Investigational Site
Lille,
FranceSite Not Available
Sobi Investigational Site
Marseille,
FranceSite Not Available
Sobi Investigational Site
Strasbourg,
FranceSite Not Available
Sobi Investigational Site
Athens,
GreeceSite Not Available
Sobi Investigational Site
Catanzaro,
ItalySite Not Available
Sobi Investigational Site
Florence,
ItalySite Not Available
Sobi Investigational Site
Milan,
ItalySite Not Available
Sobi Investigational Site
Milano,
ItalyActive - Recruiting
Sobi Investigational Site
Naples,
ItalyActive - Recruiting
Sobi Investigational Site
Parma,
ItalySite Not Available
Sobi Investigational Site
Rome,
ItalySite Not Available
Sobi Investigational Site
Vicenza,
ItalySite Not Available
Sobi Investigational Site
A Coruña,
SpainActive - Recruiting
Sobi Investigational Site
Valencia,
SpainSite Not Available
Sobi Investigational Site
Zaragoza,
SpainActive - Recruiting
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