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

NCT02319005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2018-07-18

Study results available
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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

DRUG

Revusiran (ALN-TTRSC)

DRUG

Sterile Normal Saline (0.9% NaCl)

Sponsors & Collaborators

Principal Investigators

  • Jared Gollob, MD · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-03-30
Completion
2017-03-30

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319005 on ClinicalTrials.gov