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

• Status: Completed
• Trial end date: 2017-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

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