An Open-label, Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products, Damactocog Alfa Pegol or Turoctocog Alfa Pegol, After a Single Intravenous Dose of 50 IU/kg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A.

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 (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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Sobi Investigational site
RECRUITING
Frankfurt
Sobi Investigational Site
RECRUITING
Oldenburg
Italy
Sobi Investigational Site
RECRUITING
Milan
Sobi Investigational Site
NOT_YET_RECRUITING
Naples
Spain
Sobi Investigational Site
RECRUITING
A Coruña
Sobi Investigational Site
RECRUITING
Valencia
Sobi Investigational Site
RECRUITING
Zaragoza
Contact Information
Primary
Blank Clinical Study Physician, MD PhD
medical.info@sobi.com
+46 8 697 20 00
Backup
Clinical Program Leader
medical.info@sobi.com
+46 8 697 20 00
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2025-10-28
Participants
Target number of participants: 24
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: PSI CRO
Leads: Swedish Orphan Biovitrum

This content was sourced from clinicaltrials.gov