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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05042440
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date August 11, 2021
Completion date November 24, 2021

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