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NCT04179643 · ClinicalTrials.gov registry record · Phase 1
AB-1002 in Patients With Class III Heart Failure
A Phase 1 study of Heart Failure and Cardiovascular Diseases, sponsored by AskBio.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 4
- Study locations
NCT04179643 is a Phase 1 study of Heart Failure and Cardiovascular Diseases that is active but no longer recruiting, run by AskBio. The registered enrollment target is 17 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT04179643, a Phase 1 study of Heart Failure and Cardiovascular Diseases, is active but no longer recruiting, sponsored by AskBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 4
- Study locations
Study 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).
Conditions Studied
Interventions
- BIOLOGICAL 3 x 10e13vg AB-1002
Study Locations (4)
Ohio
- The Linder Center for Education and Research at The Christ Hospital - Cincinnati
- The Ohio State University - Columbus
Minnesota
- Minneapolis Heart Foundation Institute - Minneapolis
Wisconsin
- University of Wisconsin at Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04179643
The ClinicalTrials.gov registry entry for NCT04179643 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is AskBio, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which 3 x 10e13vg AB-1002 is the first listed.
NCT04179643 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Minnesota, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04179643 about?
NCT04179643 is a clinical study titled "AB-1002 in Patients With Class III Heart Failure". 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...
What is the current status of trial NCT04179643?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-11-20. Estimated completion is 2026-09-30.
What conditions does trial NCT04179643 study?
This clinical trial studies the following conditions: Heart Failure, Cardiovascular Diseases, Congestive Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic.
What interventions are being tested in trial NCT04179643?
The interventions under investigation include: 3 x 10e13vg AB-1002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04179643?
This trial is sponsored by AskBio, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04179643 being conducted?
This trial has 4 study locations across Minnesota, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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