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

Status:	Completed
Conditions:	Cardiology, Hematology
Therapuetic Areas:	Cardiology / Vascular Diseases, Hematology
Healthy:	No
Age Range:	18 - 90
Updated:	7/20/2018
Start Date:	December 2014
End Date:	March 30, 2017

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)

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.

Inclusion Criteria:

- Documented TTR mutation

- Amyloid deposits in cardiac or non-cardiac tissue

- Medical history of heart failure

- Evidence of cardiac involvement by echocardiogram

Exclusion Criteria:

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

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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)

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