NCT03520712

A Phase 1/2 Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL and Pre-existing Antibodies Against AAV5

Study Summary

This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe Hemophilia A patients with pre-existing antibodies against AAV5.

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Interventions

Valoctocogene RoxaparvovecBIOLOGICAL
Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A

Study Locations

FacilityCityStateCountry
Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care CenterJohannesburgSouth Africa
Kyung Hee University Hospital at GangdongSeoulSouth Korea
Severance Hospital, Yonsei University Health SystemSeoulSouth Korea
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung CityTaiwan
Taichung Veterans General HospitalTaichungTaiwan
National Taiwan University HospitalTaipeiTaiwan
Tri-Service General HospitalTaipeiTaiwan
Royal Free HospitalLondonUnited Kingdom
University Hospital Southampton NHS Foundation TrustSouthamptonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026