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Clinical Trial Report

Gene Therapy Trial Report

Summary

AC6 Gene Transfer for CHF


NCTID NCT00787059 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Congestive Heart Failure
Disease Ontology Term DOID:9651
Compound Name RT-100
Compound Description Ad5.CMV.hAC6
Sponsor Hammond, H. Kirk, M.D.
Funder Type Indiv
Recruitment Status
Completed
Enrollment Count 56
Results Posted Not Available

Therapy Information


Target Gene/Variant ADCY6
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intracoronary
Drug Product Type Viral vector
Target Tissue/Cell Myocardium
Delivery System Viral transduction
Vector Type Ad5
Editor Type
Dose 1 3.2E9 vp (n=6)
Dose 2 3.2E10 vp (n=6)
Dose 3 1E10 vp (n=6)
Dose 4 3.2E11 vp (n=12)
Dose 5 1E12 vp (n=12)

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2008-11-06
Completion Date 2017-11-16
Last Update 2018-02-09

Participation Criteria


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

Locations


No.of Trial Sites 7
Locations United States

Regulatory Information


Has US IND True
FDA Designations Fast Track
Recent Updates Company is preparing to submit a plan to the FDA for the Phase 2b/3 study

Resources/Links