Status:
RECRUITING
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Lead Sponsor:
Swedish Orphan Biovitrum
Collaborating Sponsors:
PSI CRO
Conditions:
Hemophilia A
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa p...
Eligibility Criteria
Inclusion
- Participant must be male, 18 to 65 years of age, inclusive, at the time of signing the informed consent form (ICF).
- Severe haemophilia A, defined as \<1 IU/dL (\<1%) endogenous FVIII activity, as documented in historical medical records from a clinical laboratory demonstrating \<1% FVIII coagulant activitiy or a documented genotype known to produce severe haemophilia A.
- Previous treatment for haemophilia A with any marketed recombinant and/or plasma derived FVIII for at least 150 exposure days.
- Currently receiving treatment with damoctocog alfa pegol or turoctocog alfa pegol at Screening.
Exclusion
- Any history of a positive inhibitor test, defined as \>0.6 Bethesda units (BU)/mL in at least two consecutive Bethesda inhibitor assays, or any value greated than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL. Family history of inhibitors will not exclude the participant.
- Positive FVIII inhibitor result (assessed by central laboratory), defined as ≥0.6 BU/mL at Screening.
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 28 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06579144
Start Date
February 24 2025
End Date
May 28 2026
Last Update
December 17 2025
Active Locations (7)
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1
Sobi Investigational site
Frankfurt, Germany
2
Sobi Investigational Site
Oldenburg, Germany
3
Sobi Investigational Site
Milan, Italy
4
Sobi Investigational Site
Naples, Italy