Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A

Last updated: June 23, 2026
Sponsor: Swedish Orphan Biovitrum
Overall Status: Completed

Phase

1

Condition

Hemophilia

Blood Clots

Treatment

Efanesoctocog alfa

Clinical Study ID

NCT06579144
Sobi.BIVV001-003
  • Ages 18-65
  • Male

Study 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 pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia A.

Participants who are receiving treatment with damoctocog alfa pegol (n12) or turoctocog alfa pegol (n12) will be enrolled in the study. The study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period.

During the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant's pre-study treatment) will be administered. A PK sampling period will follow over 7 visits. Following completion of the PK sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new PK sampling period will follow (visit 8-15).

The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections.

Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be male, 18 to 65 years of age, inclusive, at the time of signingthe informed consent form (ICF).

  • Severe haemophilia A, defined as <1 IU/dL (<1%) endogenous FVIII activity, asdocumented in historical medical records from a clinical laboratory demonstrating <1% FVIII coagulant activity or a documented genotype known to produce severehaemophilia A.

  • Previous treatment for haemophilia A with any marketed recombinant and/or plasmaderived FVIII for at least 150 exposure days.

  • Currently receiving treatment with damoctocog alfa pegol or turoctocog alfa pegol atScreening.

Exclusion

Exclusion Criteria:

  • Any history of a positive inhibitor test, defined as >0.6 Bethesda units (BU)/mL inat least two consecutive Bethesda inhibitor assays, or any value greater than orequal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitordetection between 0.7 and 1.0 BU/mL. Family history of inhibitors will not excludethe participant.

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

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Efanesoctocog alfa
Phase: 1
Study Start date:
February 24, 2025
Estimated Completion Date:
May 21, 2026

Connect with a study center

  • Sobi Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • Sobi Investigational Site

    Bonn,
    Germany

    Site Not Available

  • Sobi Investigational site

    Frankfurt,
    Germany

    Site Not Available

  • Sobi Investigational Site

    Milan,
    Italy

    Site Not Available

  • Sobi Investigational Site

    A Coruña,
    Spain

    Site Not Available

  • Sobi Investigational Site

    Valencia,
    Spain

    Site Not Available

  • Sobi Investigational Site

    Zaragoza,
    Spain

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.