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Phosphatase Inhibitor

AB-1002 for Heart Failure (GenePHIT Trial)

Phase 2

Recruiting

Research Sponsored by Asklepios Biopharmaceutical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with chronic non-ischemic cardiomyopathy

Medically stable, NYHA Class III HF (New York Heart Association Functional Classification) for a minimum of 4 weeks while on appropriate medical therapy including beta blocker therapy, ACE inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment, and stable doses of aldosterone antagonist therapy for ≥ 30 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

GenePHIT Trial Summary

This trial is testing a single dose of a drug to see if it can help people with heart failure symptoms.

Who is the study for?

Adults over 18 with non-ischemic cardiomyopathy and NYHA Class III heart failure symptoms, who can walk more than 50 meters. They must have a left ventricular ejection fraction of 15-35%, be on stable heart medications, and if applicable, use reliable contraception. Excluded are those with recent severe heart issues, other serious health conditions or treatments that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing AB-1002's safety and effectiveness for heart failure when given through an artery in the heart. Participants will be randomly assigned to one of three groups to receive either AB-1002 or a placebo in equal ratios.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical risks associated with gene therapy such as immune reactions, infusion-related responses, or complications from the delivery method into the coronary artery.

GenePHIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a long-term heart muscle disease not caused by blocked arteries.

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My heart condition has been stable for at least 4 weeks, and I've been on specific heart medications for over 3 months.

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I am 18 years old or older.

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I can walk more than 50 meters in 6 minutes.

GenePHIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiovascular Related Death

Left Ventricular Ejection Fraction

NYHA Classification

+2 more

Secondary outcome measures

Heart failure

GenePHIT Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group 2 AB-1002Experimental Treatment1 Intervention

Randomized in 1:1:1 into one of three groups. Group 2: 6.5E13vg (n=30-50)

Group II: AB-1002Experimental Treatment1 Intervention

Randomized in 1:1:1 into one of three groups. Group 1: 3.25E13vg (n=30-50)

Group III: Treatment Group 3Placebo Group1 Intervention

Randomized in 1:1:1 into one of three groups. Group 3: Placebo (n=30-50)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Asklepios Biopharmaceutical, Inc.Lead Sponsor

7 Previous Clinical Trials

283 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has AB-1002 obtained regulatory clearance from the FDA?

"AB-1002's safety has a rating of 2 since the existing clinical data only provides evidence for its security and not efficacy."

Answered by AI

Are there any vacancies available for individuals to partake in this research?

"This trial, originally posted on September 15th 2023 and last amended a few days later, is not currently recruiting. Despite this, there are 763 other clinical trials that are actively seeking patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure

2023. "Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05598333.

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