Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
← catalyst calendarNCT06716814 · readout ≤ 224 d
Sponsored by Swedish Orphan Biovitrum (industry) · SOBI.ST — their whole pipeline →. With PSI CRO.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
104estimated
Sites
21
Countries
Bulgaria, France, Greece +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-06 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Haemophilia A (Moderate or Severe)
Intervention
- Drug: Efanesoctocog alfa — also filed as BIVV001, Altuvoct, Altuviiio, Recombinant coagulation factor VIII Fc-von-Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)
Primary outcomes
what the primary-completion date above is the date OFNumber of injections to treat a bleeding episode
measured From enrollment and up to 52 weeks
Total dose to treat a bleeding episode
measured From enrollment and up to 52 weeks
Adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)
measured From enrollment and up to 52 weeks
Annualized bleeding rate (ABR) for treated bleeding episodes
measured From enrollment and up to 52 weeks
Annualized bleeding rate (ABR) for treated bleeding episodes by type of bleed
measured From enrollment and up to 52 weeks
Annualized bleeding rate (ABR) for treated bleeding episodes by location of bleed
measured From enrollment and up to 52 weeks
Annualized bleeding rate (ABR) for all bleeding episodes
measured From enrollment and up to 52 weeks
Annualized bleeding rate (ABR) for all bleeding episodes by type of bleed
measured From enrollment and up to 52 weeks
Annualized bleeding rate (ABR) for all bleeding episodes by location of bleed
measured From enrollment and up to 52 weeks
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