Study of AG10 in Amyloid Cardiomyopathy (NCT03458130) | Clinical Trial Compass
CompletedPhase 2
Study of AG10 in Amyloid Cardiomyopathy
United States49 participantsStarted 2018-04-27
Plain-language summary
This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization will be followed by a 28-day blinded, placebo-controlled treatment period.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
✓. Be a male or female ≥18 to ≤90 years of age.
✓. Have an established diagnosis of ATTR-CM with either wild-type transthyretin or a variant transthyretin genotype (assessed by genotyping, with patients with concurrent monoclonal gammopathy of undetermined significance requiring a confirmatory test using mass spectrometry) as defined by either positive endomyocardial biopsy or positive technetium pyrophosphate scan.
✓. Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure (without hospitalization) requiring medical management.
✓. Have New York Heart Association (NYHA) Class II-III symptoms.
✓. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use appropriate method(s) of contraception.
✓. For patients taking cardiovascular medical therapy, with the exception of diuretic dosing, must be on stable doses (defined as no greater than 50% dose adjustment and no categorical changes of medications) for at least 2 weeks prior to Screening.
Exclusion criteria
✕. Acute myocardial infarction, acute coronary syndrome or coronary revascularization within 90 days prior to Screening.
✕. Experienced stroke within 90 days prior to Screening.
. Has hemodynamic instability at Screening or Randomization that, in the judgment of the Principal Investigator (PI), would pose too great a risk for participation in the study.
✕. Has estimated glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 at Screening.
✕. Is likely to undergo heart transplantation within the next year.
✕. Has confirmed diagnosis of light-chain amyloidosis.
✕. Has abnormal liver function tests at Screening, defined as Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \>3 × upper limit of normal (ULN) or total bilirubin \>2 × ULN.
✕. Has abnormalities in clinical laboratory tests at Screening or Randomization that, in the judgment of the PI, would pose too great a risk for participation in the study.