ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)

Trial ID or NCT#

NCT02319005

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has been discontinued; patients are being followed-up for safety.

Official Title

A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)

Eligibility Criteria

Ages Eligible for Study: 18 to 90
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Documented TTR mutation* Amyloid deposits in cardiac or non-cardiac tissue* Medical history of heart failure* Evidence of cardiac involvement by echocardiogram
Exclusion Criteria:
  1. * Has known primary amyloidosis (AL), leptomeningeal amyloidosis, non-FAC hereditary cardiomyopathy, hypertensive cardiomyopathy, or cardiomyopathy due to valvular heart disease* Has known peripheral vascular disease affecting ambulation* Has a Polyneuropathy Disability score \>2* Has a New York Heart Association (NYHA) classification of IV
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Investigator(s)

Ronald M Witteles
Ronald M Witteles
Cardiologist, Heart failure cardiologist
Professor of Medicine (Cardiovascular Medicine)

View on ClinicalTrials.gov