NCT03588299

A Phase 1/2 Open-label Safety and Dose-finding Study of BAY2599023 (DTX201), an Adeno-associated Virus (AAV) hu37-mediated Gene Transfer of B-domain Deleted Human Factor VIII, in Adults With Severe Hemophilia A

Study Summary

In this study researchers want to gather more information about safety and effectiveness of BAY 2599023 (DTX201), a drug therapy that delivers the human factor VIII gene into the human body by use of a viral vector to treat the disease. By replacing the defective gene with a healthy copy the human body may produce clotting factor on its own. Hemophilia A is a bleeding disorder in which the human body does not have enough clotting factor VIII, a protein that controls bleeding. Researcher want to find the optimal dose of BAY 2599023 (DTX201) so that the body may produce enough clotting factor on its own.

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Interventions

BAY2599023 (DTX201)DRUG
Single escalating doses with 4 dose steps; Single intravenous (IV) administration.

Study Locations

FacilityCityStateCountry
Arkansas Children's Hospital - Hematology / OncologyLittle RockArkansasUnited States
C.S. Mott Children's Hospital - Hematology / OncologyAnn ArborMichiganUnited States
UW Health Carbone Cancer CenterMadisonWisconsinUnited States
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EADSofiaSofia City ProvinceBulgaria
CHU Rennes - Hopital PontchaillouRennesBrittany RegionFrance
APHP-Hopital Necker Enfants maladesParisÎle-de-France RegionFrance
Universitätsklinikum des SaarlandesHomburgSaarlandGermany
Vivantes Klinikum im FriedrichshainBerlinGermany
Academisch Medisch Centrum (AMC)AmsterdamNorth HollandNetherlands
Erasmus Medisch CentrumRotterdamSouth HollandNetherlands
Universitair Medisch Centrum GroningenGroningenNetherlands
University Medical Center UtrechtUtrechtNetherlands
Manchester Royal InfirmaryManchesterGreater ManchesterUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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