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ACTIVE NOT RECRUITING
NCT04179643
PHASE1

AB-1002 in Patients With Class III Heart Failure

Sponsor: AskBio Inc

View on ClinicalTrials.gov

Summary

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. Patients with non-ischemic cardiomyopathy will be enrolled until up to 17 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

Official title: Phase 1 Open Label, Dose Escalation Trial of Intracoronary Infusion of AB-1002 in Subjects With NYHA Class III Heart Failure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2019-11-20

Completion Date

2026-09-30

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

3 x 10e13vg AB-1002

There are 2 components to AB-1002. The first is an active I-1 transgene (AA 1-65 with T35D), and the second is the vector, BNP116, which delivers the gene selectively to the heart after intracoronary administration.

Locations (4)

Minneapolis Heart Foundation Institute

Minneapolis, Minnesota, United States

The Linder Center for Education and Research at The Christ Hospital

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Wisconsin at Madison

Madison, Wisconsin, United States