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

Launched by SWEDISH ORPHAN BIOVITRUM · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called efanesoctocog alfa for men with severe Hemophilia A, a condition that affects the blood's ability to clot. The researchers want to compare how long efanesoctocog alfa stays in the body compared to two other treatments that are already available: damoctocog alfa pegol and turoctocog alfa pegol. The study involves participants who have been using one of these two existing treatments and will consist of two parts where each participant will receive both their current treatment and efanesoctocog alfa in a specific order.

To be eligible for this trial, participants must be males aged 18 to 65 who have severe Hemophilia A and have previously received treatment for at least 150 days. Participants will first undergo a screening process, and if they qualify, they will receive doses of the medications and provide samples for testing over several visits. The trial not only aims to see how well efanesoctocog alfa works but also to ensure it is safe to use. This study is currently recruiting participants, so if you or someone you know meets the criteria, it could be an opportunity to contribute to important research in Hemophilia A treatment.

Gender

MALE

Eligibility criteria

• 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.