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

NCT02928094 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-07-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Huapont Life Sciences

    collaborator UNKNOWN

  • Angionetics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-03-01
Completion
2024-12-31
FDA Drug
Yes

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Drugs

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 NCT02928094 on ClinicalTrials.gov