Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 5, 2024

Primary Completion Date

December 1, 2027

Study Completion Date

April 30, 2031

Conditions
Fabry Disease
Interventions
DRUG

AMT-191

"A recombinant serotype 5 based adeno-associated viral vector (AMT-191) for one-time intravenous (IV) administration will be investigated in this study. This recombinant AAV5-based vector contains a coding deoxyribonucleic acid (DNA) sequence for human α-galactosidase A.~Delivery of AMT-191 to the systemic circulation is expected to result in a therapeutic effect by promoting the liver expression of the lysosomal enzyme GLA in plasma levels in patients with Fabry disease."

Trial Locations (8)

10029

RECRUITING

NYC Health + Hospitals/Metropolitan, New York

15224

RECRUITING

UPMC Children's Hospital of Pittsburgh, Pittsburgh

22030

RECRUITING

Lysosomal & Rare Disorders Research and Treatment Center, Inc, Fairfax

30322

RECRUITING

Emory University School of Medicine, Atlanta

35233

RECRUITING

The Kirklin Clinic Of university of Alabama Birmingham Hospital, Birmingham

55455

RECRUITING

MHealth Fairview University of Minnesota Medical Center East Bank, Minneapolis

60611

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

84108

RECRUITING

University of Utah, Clinical and Translational Sciences Institute, Salt Lake City

All Listed Sponsors
lead

UniQure Biopharma B.V.

INDUSTRY