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Clinical Trial Report

Gene Therapy Trial Report

Summary

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction


NCTID NCT04703842 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Congestive Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
Disease Ontology Term DOID:9651
Compound Name SRD-001
Compound Description AAV1-CMV-SERCA2a
Sponsor Sardocor Corp.
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 57
Results Posted Not Available

Therapy Information


Target Gene/Variant SERCA2a
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
Delivery System Viral transduction
Vector Type AAV1
Editor Type none
Dose 1 3E13 vg
Dose 2 4.5E13 vg
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2021-01-07
Completion Date 2028-12
Last Update 2024-03-26

Participation Criteria


Eligible Age 18 Years - 80 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 5
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates Anticipated Phase 2b in 4Q2024-1Q2025

Resources/Links