NCT02319005

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
• Amyloidosis, Hereditary
• Amyloid Neuropathies, Familial
• Amyloid Neuropathies
• Amyloidosis, Hereditary, Transthyretin-Related
• Familial Transthyretin Cardiac Amyloidosis

Interventions

Type	Name	Description
DRUG	Revusiran (ALN-TTRSC)
DRUG	Sterile Normal Saline (0.9% NaCl)

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-03-30
• Completion: 2017-03-30
• First posted: 2014-12-18
• Last updated: 2018-07-18
• Results posted: 2018-07-18

Locations

61 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom