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Clinical Trial Report

Gene Therapy Trial Report

Summary

Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure


NCTID NCT05598333 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Congestive Heart Failure
Disease Ontology Term DOID:6000
Compound Name AB-1002
Compound Description BNP116.sc-CMV.I1c
Sponsor AskBio Inc
Funder Type Industry
Recruitment Status
Enrollment Count 150
Results Posted Not Available

Therapy Information


Target Gene/Variant PPP1R1A
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intraarterial
Drug Product Type Viral vector
Target Tissue/Cell Cardiomyocyte
Delivery System Viral transduction
Vector Type AAV2i8
Editor Type none
Dose 1 3.25E13 vg
Dose 2 6.5E13 vg
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase2
Submit Date 2022-10-25
Completion Date 2030-12-31
Last Update 2025-04-09

Participation Criteria


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

Locations


No.of Trial Sites 43
Locations Austria,Netherlands,United States,United Kingdom,Germany,Spain

Regulatory Information


Has US IND True
FDA Designations Fast Track
Recent Updates Received Fast Track designation 4/18/24

Resources/Links