NCT05042440

Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A

A Phase 1, Single-Site, Open-Label Study to Assess Pharmacokinetics of Efanesoctocog Alfa (BIVV001), Standard Half-Life and Extended Half-Life FVIII After Each Single Intravenous Injection in a Fixed Sequence, in Previously Treated Adults With Severe Hemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary objective • To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives * To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection * To evaluate the safety and tolerability of a single IV injection of BIVV001

Detailed description

This is a Phase 1, single center, open-label, sequential treatment, 3-period fixed sequence study to assess PK profiles of BIVV001, SHL and EHL rFVIII after a single IV injection in male, previously treated patients, 18-65 years of age, with severe hemophilia A (defined as \<1 IU/dL \[\<1%\] endogenous FVIII). The expected duration of the study is up to approximately 67 days including * Screening and washout up to 28 days, * Advate® dosing, PK sampling, including washout: approximately 4 days, * Adynovi® dosing and PK sampling, including washout: approximately 7 days, * BIVV001 dosing and PK sampling: approximately 14 days, Remainder of Safety Observation Period: approximately 14 days.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Efanesoctocog alfa	Solution for injection Intravenous
DRUG	Octocog alfa	Solution for injection Intravenous
DRUG	Rurioctocog alfa pegol	Solution for injection Intravenous

Timeline

• Start date: 2021-08-11
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2021-09-13
• Last updated: 2025-09-18

Locations

1 site across 1 country: Bulgaria