Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Swedish Orphan Biovitrum
With
PSI CRO
Age
6–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Capable of giving signed informed consent. Parents or legally designated representatives' consent is required for patients who are below 18 years of age or unable to give consent. Patients who are below 18 years of age may provide assent in addition to the parents'/legally designated representatives' consent, if appropriate.
Must have completed one of the required parent studies: Sobi.BIVV001-001, Sobi.BIVV001-003, LTS16294, or Sobi.BIVV001-004, and be receiving a clinical benefit from the efanesoctocog alfa treatment, as judged by the Investigator.
Willingness and ability of patient or their parent or legally designated representative to complete training in the use of the study patient diary and to complete the diary throughout the study.
You may not be if
Positive inhibitor result, defined as ≥0.6 Bethesda units (BU)/mL, present at the Baseline Visit.
Ongoing or planned participation in any interventional clinical study at the Baseline Visit.
Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
Clareo Health | Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
