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Clinical Trial Report

Gene Therapy Trial Report

Summary

A Fabry Disease Gene Therapy Study


NCTID NCT04040049 (View at clinicaltrials.gov)
Description
Development Status Inactive
Indication Fabry Disease
Disease Ontology Term DOID:14499
Compound Name FLT190
Compound Description AAV2/S3.FRE1.GLAco
Sponsor Spur Therapeutics
Funder Type Industry
Recruitment Status
Terminated
Enrollment Count 3
Results Posted Not Available

Therapy Information


Target Gene/Variant GLA
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Intravenous
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAVS3
Editor Type
Dose 1 7.5E11 vg/kg
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2019-07-26
Completion Date 2023-05-02
Last Update 2023-06-05

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study MALE

Locations


No.of Trial Sites 13
Locations Canada,Austria,United States,Norway,Italy,United Kingdom,Germany

Regulatory Information


Has US IND True
FDA Designations
Recent Updates Development cancelled to prioritize other programs

Resources/Links