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

NCT ID: NCT06579144

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2026-05-28

Brief Summary

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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 (n\~12) or turoctocog alfa pegol (n\~12) 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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Open-label, 2-period, fixed-sequence study for intra-participant comparison of PK-profiles.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Damactocog alfa pegol

Patients treated with damactocog alfa pegol at the time of screening will receive one single injection with 50 IU/kg at visit 1, then one single dose 50 IU/kg with efanesoctocog alfa at visit 8.

Group Type ACTIVE_COMPARATOR

Efanesoctocog alfa

Intervention Type DRUG

Recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)

Turoctocog alfa pegol

Patients treated with turoctocog alfa pegol at the time of screening will receive one single injection with 50 IU/kg at visit 1, then one single dose 50 IU/kg with efanesoctocog alfa at visit 8.

Group Type ACTIVE_COMPARATOR

Efanesoctocog alfa

Intervention Type DRUG

Recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)

Interventions

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Efanesoctocog alfa

Recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)

Intervention Type DRUG

Other Intervention Names

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BIVV001 Altuvoct Altuviiio

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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PSI CRO

INDUSTRY

Sponsor Role collaborator

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Santagostino, MD

Role: STUDY_DIRECTOR

Sobi AB

Locations

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Sobi Investigational site

Frankfurt, , Germany

Site Status RECRUITING

Sobi Investigational Site

Oldenburg, , Germany

Site Status RECRUITING

Sobi Investigational Site

Milan, , Italy

Site Status RECRUITING

Sobi Investigational Site

Naples, , Italy

Site Status NOT_YET_RECRUITING

Sobi Investigational Site

A Coruña, , Spain

Site Status RECRUITING

Sobi Investigational Site

Valencia, , Spain

Site Status RECRUITING

Sobi Investigational Site

Zaragoza, , Spain

Site Status RECRUITING

Countries

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Germany Italy Spain

Central Contacts

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Blank Clinical Study Physician, MD PhD

Role: CONTACT

[email protected]
+46 8 697 20 00

Clinical Program Leader

Role: CONTACT

[email protected]
+46 8 697 20 00

Facility Contacts

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Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Other Identifiers

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Sobi.BIVV001-003

Identifier Type: -

Identifier Source: org_study_id