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

NCT05042440 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-09-18

No results posted yet for this study

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

Conditions

Interventions

DRUG

Efanesoctocog alfa

Solution for injection Intravenous

DRUG

Octocog alfa

Solution for injection Intravenous

DRUG

Rurioctocog alfa pegol

Solution for injection Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences and Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2021-11-24
Completion
2021-11-24

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05042440 on ClinicalTrials.gov