NCT02928094

Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Ad5FGF-4 in Patients With Refractory Angina Due to Myocardial Ischemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Angionetics Inc. · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a single intracoronary infusion of an adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4 (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life. Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT) duration. Long-term safety of Ad5FGF-4 will also be assessed.

Conditions

• Angina, Stable

Interventions

Type	Name	Description
BIOLOGICAL	Ad5FGF-4	Ad5FGF-4 administered via intracoronary infusion using standard balloon catheter, and under conditions of transient ischemia.
BIOLOGICAL	Placebo	Placebo buffer administered via intracoronary infusion using standard balloon catheter, without transient ischemia.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-03-01
• Completion: 2024-12-31
• First posted: 2016-10-10
• Last updated: 2022-07-19

Regulatory

• FDA-regulated drug study