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Ab-1002

Clinical trials are investigating Ab-1002 in adults with congestive heart failure and non-ischemic cardiomyopathy. The main goal is to see whether it is safe and whether it can improve heart failure outcomes compared with placebo. The study focuses on people with NYHA Class III symptoms.

Table of contents

Trial overview

The main study of Ab-1002 is GenePHIT, a Phase 2 interventional trial in adults with congestive heart failure and non-ischemic cardiomyopathy.[1] The study is designed to learn more about both efficacy and safety, which means whether the treatment may help and whether it can be used with acceptable risk in the study setting.[1]

This trial is authorised and plans to compare Ab-1002 with placebo in people with NYHA Class III heart failure symptoms.[1] The brief summary says the study looks at a single antegrade intracoronary artery infusion of AB-1002 versus placebo infusion.[1]

Who can join the study

The trial includes adult subjects with NYHA Class III congestive heart failure and non-ischemic cardiomyopathy.[1] NYHA Class III means symptoms happen with ordinary activity or even less activity than usual, so this group has clear heart failure limitations in daily life.[1]

Non-ischemic cardiomyopathy means the heart muscle is weak or abnormal, but the problem is not caused by blocked heart arteries.[1] The study information does not list more detailed inclusion or exclusion rules, so only this target population can be confirmed from the source data.[1]

What is being measured

The main outcome is a modified win ratio at 52 weeks.[1] A win ratio is a way to compare two groups by ranking several outcomes in order of importance, rather than using just one result.[1]

The study uses a hierarchical order of outcomes: cardiovascular related death, change in NYHA class, change in LVEF, and change in the six-minute walk test.[1] In simple terms, the trial first looks at the most serious outcome, then at heart failure symptoms, then at heart pumping function, and then at walking ability.[1]

LVEF stands for left ventricular ejection fraction, which is a measure of how much blood the heart pumps out with each beat.[1] For this study, a responder is defined as someone with at least a 5% increase in LVEF.[1] For the six-minute walk test, a responder is defined as someone who improves by more than 30 meters.[1]

Safety monitoring

The trial also checks safety over the 52-week observation period.[1] Researchers will track treatment-emergent adverse events and serious adverse events, which are unwanted medical problems that appear after treatment starts.[1]

Safety monitoring also includes lab tests, vital signs, and electrocardiograms, also called ECGs.[1] Lab tests look at body chemistry, vital signs include basic measures such as blood pressure and pulse, and ECGs record the heart’s electrical activity.[1]

Study design and treatment groups

This is an interventional study, meaning the research team assigns the treatment rather than only observing what happens in routine care.[1] Participants are assigned to Ab-1002 or placebo, so the study can compare outcomes between the two groups.[1]

The summary describes a single antegrade intracoronary artery infusion, which means the study treatment is given into a coronary artery in the direction of blood flow.[1] The source data does not provide more detail about visit schedules or other study procedures beyond the 52-week observation period.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 323 participants, which is the number of people the study aims to include.[1]

At present, the available data shows one registered trial for Ab-1002 in this heart failure setting.[1] The study is focused on a specific group of adults with symptomatic heart failure, so the results will mainly apply to that population.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05598333 Phase 2 NYHA Class III congestive heart failure and non-ischemic cardiomyopathy Authorised 323

FAQ

  • What is being studied in Ab-1002 trials? The trial is studying whether Ab-1002 can improve heart failure outcomes and whether it is safe. It compares Ab-1002 with placebo, which is a look-alike treatment with no active study drug.
  • Who can join the Ab-1002 study? The study includes adult participants with New York Heart Association (NYHA) Class III congestive heart failure and non-ischemic cardiomyopathy. These are people with significant heart failure symptoms caused by a heart muscle problem not due to blocked heart arteries.
  • What phase is the Ab-1002 trial? This is a Phase 2 trial. Phase 2 studies look at early signs of benefit and continue to assess safety in a defined group of patients.
  • What results are being measured? The main result is a modified win ratio at 52 weeks. This includes death from heart disease, change in NYHA class, change in left ventricular ejection fraction (LVEF, a measure of how well the heart pumps), and change in the six-minute walk test.
  • How many people are planned for the study? The trial plans to enroll 323 participants. It is an interventional study, which means researchers assign the study treatment and compare outcomes.

Ongoing Clinical Trials on Ab-1002

  • Study of AB-1002 gene therapy given through coronary arteries in adults with severe (NYHA Class III) heart failure caused by non-ischemic cardiomyopathy

    Not recruiting

    1
    Investigated drugs:
    Austria Belgium Bulgaria Germany Hungary The Netherlands +3

Glossary

  • Congestive heart failure: A condition where the heart does not pump blood as well as it should, which can cause tiredness, shortness of breath, and swelling.
  • Non-ischemic cardiomyopathy: A disease of the heart muscle that is not caused by blocked heart arteries. It can weaken the heart's ability to pump.
  • NYHA Class III: A heart failure severity level. Class III means symptoms happen with less-than-normal activity, so daily tasks may be harder.
  • Placebo: A look-alike treatment that does not contain the active study drug. It is used to compare results fairly.
  • Phase 2: A stage of clinical research that checks early signs of benefit and continues to study safety in a group of patients.
  • Interventional study: A study where researchers assign a treatment or procedure and then measure what happens.
  • LVEF: Left ventricular ejection fraction. This is a measure of how much blood the left side of the heart pumps out with each beat.
  • Six-minute walk test (6MWT): A simple test that measures how far a person can walk in six minutes. It helps show physical ability and exercise tolerance.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: A more severe unwanted medical problem, such as one that is life-threatening, requires hospital care, or causes major harm.

References