Basic Information

Gene symbol ADCY6 Synonyms AC6, LCCS8 Type of gene protein-coding
Description adenylate cyclase 6

GTO ID GTC0068
Trial ID NCT00787059
Disease Congestive Heart Failure
Altered gene AC6
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment Ad5.hAC6
PhasePhase1|Phase2
Recruitment statusCompleted
TitlePhase I/II Study AC6 Gene Transfer for Congestive Heart Failure
Year2008
CountryUnited States
Company sponsorHammond, H. Kirk, M.D.
Other ID(s)365|P01HL066941
Vector information
Vectoradenovirus
ConstructAd5.hAC6
Vector typereplication-deficient adenovirus serotype 5 vector
Transgene/Inserted genehuman adenylyl cyclase type 6 gene
Regulatory elementa cytomegalovirus (CMV) promoter
Viral genome modificationThe E1 and E3 regions of the parental adenovirus DNA are deleted.

Clinical Result

Cohort1: Ad5.hAC6
Administration route None
Dosage 3.2E9~E12 virus particles
Pts 42
Age Adult, Older_Adult
Outcome Exercise duration showed no significant differences at 4 weeks (P = .27) or 12 weeks (P = .47). The Ad5.hAC6 group experienced a significant increase in ejection fraction (EF) at 4 weeks (+6.0 EF units; P < .004), but not at 12 weeks (+3.0 EF units; P = .16). Basal left ventricular peak -dP/dt increased at 4 weeks (P < .03), and there was no increase in arrhythmias. The heart failure admission rate for the Ad5.hAC6 group was 9.5% (4 of 42), with a relative risk of 0.33 (95% CI, 0.08-1.36; P = .10) compared to the placebo group.
Adverse reactions 18/43(serious adverse event)
References PMID: 27437887
Cohort2: placebo
Administration route None
Dosage placebo
Pts 14
Age Adult, Older_Adult
Outcome Exercise duration showed no significant differences compared to the Ad5.hAC6 group at 4 weeks (P = .27) or 12 weeks (P = .47). The placebo group showed no increase in ejection fraction (EF) at either 4 weeks or 12 weeks. Basal left ventricular peak -dP/dt showed no significant changes, with a 4-week change from baseline of +93 mm Hg/s. The heart failure admission rate for the placebo group was 28.6% (4 of 14).
Adverse reactions 5/14(serious adverse event)
References PMID: 27437887

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