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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
Must not have
Uncorrected Third degree heart block
Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe type of heart rhythm problem.
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I am HIV positive or have AIDS with low immunity.
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I am allergic to dyes used in certain heart and blood vessel imaging tests.
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I have advanced kidney disease and need dialysis or my kidney function is very low.
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I do not have a bleeding disorder or low platelet count.
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I have heart muscle damage due to blocked heart arteries.
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I have a low white blood cell count.
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I have a diagnosed liver condition.
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I have not had heart surgery or a heart procedure in the last 30 days.
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I have had heart surgery or a device implanted for heart support.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Left Ventricular Ejection Fraction
NYHA Classification
Peak Oxygen Update (VO2)
+1 moreSecondary study objectives
Heart failure
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)
Find a Location
Who is running the clinical trial?
Asklepios Biopharmaceutical, Inc.Lead Sponsor
7 Previous Clinical Trials
283 Total Patients Enrolled