Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

  • Interventional
  • Recruiting
  • NCT03860935
Eligibility Details Visit Clinicaltrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM)

Phase 3 efficacy and safety study to evaluate AG10 800 mg compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

This Phase 3 prospective, randomized, multicenter, parallel-group study will evaluate the efficacy and safety of AG10 800 mg in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM) for a total of 30 months of blinded, placebo-controlled treatment.

     At the end of 12 months of treatment (Part A) efficacy of AG10 will be assessed through analyses of the functional endpoint, 6 Minute Walk Test, and the health-related Quality of Life endpoint, heart failure-specific instrument Kansas City Cardiomyopathy Questionnaire.

     At the end of 30 months of treatment (Part B) efficacy of AG10 will be further assessed through analysis of all-cause mortality and frequency of cardiovascular-related hospitalization.

     All subjects who complete 30 months of blinded, placebo-controlled treatment may be eligible to participate in an open label extension study of long-term AG10 treatment.

Gender
All

Age Group
18 Years to 90 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR genotype

         - Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures or heart failure symptoms that required or require ongoing treatment with a diuretic.

         - New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy.

         - On stable doses of cardiovascular medical therapy

         - Completed ≥150 m on the 6MWT on 2 consecutive tests

         - Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL

         - Have left ventricular wall (interventricular septum or left ventricular posterior wall) thickness ≥13 mm

        Exclusion Criteria:

         - Had acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke within 90 days

         - Has hemodynamic instability

         - Likely to undergo heart transplantation within a year of screening

         - Confirmed diagnosis of primary (light chain) amyloidosis

         - Biomarkers of myocardial wall stress, NT-proBNP level ≥7000 pg/mL pg/mL

         - Measure of kidney function, eGFR by MDRD formula < 15 mL/min/1.73 m2

         - Current treatment with other investigational agents for the treatment of ATTR-CM

         - Current treatment with calcium channel blockers or digitalis
  • Heart Disease

At a Glance

National Government IDNCT03860935

IRB#IRB19-0400

Lead SponsorEidos Therapeutics

Lead PhysicianNitasha Sarswat

Collaborator(s)N/A

EligibilityAll
18 Years to 90 Years
Recruiting