MedTrace Logo

AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure

NCT03360448 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-06-07

No results posted yet for this study

Summary

To determine the safety and efficacy of an intracoronary injection of adenovirus 5 encoding human adenylyl cyclase 6 (RT-100) in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) in a Phase 3 clinical trial.

Conditions

Interventions

DRUG

Ad5.hAC6

1:1 randomization (Ad5.hAC6 : placebo) - intracoronary delivery

DRUG

Placebo

1:1 randomization (Ad5.hAC6 : placebo) - intracoronary delivery

Sponsors & Collaborators

  • Renova Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-06-30
Completion
2023-06-30
FDA Drug
Yes

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360448 on ClinicalTrials.gov