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

Sponsored by Alnylam Pharmaceuticals

About this trial

Last updated 7 years ago

Study ID

ALN-TTRSC-004

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 90 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Documented TTR mutation

- Amyloid deposits in cardiac or non-cardiac tissue

- Medical history of heart failure

- Evidence of cardiac involvement by echocardiogram

No

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

View clinical trial results on registries

Clinicaltrials.gov

Locations

Location

Status

For more information, view the full study details:

NCT02319005