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

Last updated: June 22, 2018
Sponsor: Alnylam Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Amyloidosis

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT02319005
ALN-TTRSC-004
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Has known primary amyloidosis (AL), leptomeningeal amyloidosis, non-FAC hereditarycardiomyopathy, hypertensive cardiomyopathy, or cardiomyopathy due to valvular heartdisease

  • Has known peripheral vascular disease affecting ambulation

  • Has a Polyneuropathy Disability score >2

  • Has a New York Heart Association (NYHA) classification of IV

Study Design

Total Participants: 206
Study Start date:
December 01, 2014
Estimated Completion Date:
March 30, 2017

Connect with a study center

  • Clinical Trial Site

    Anderlecht,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Hasselt,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Roeselare,
    Belgium

    Site Not Available

  • Clinical Trial Site

    Toronto,
    Canada

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  • Clinical Trial Site

    Bordeaux, Aquitaine
    France

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  • Clinical Trial Site

    Creteil,
    France

    Site Not Available

  • Clinical Trial Site

    Marseille,
    France

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    Paris,
    France

    Site Not Available

  • Clinical Trial Site

    Heidelberg,
    Germany

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  • Clinical Trial Site

    Muenster,
    Germany

    Site Not Available

  • Clinical Trial Site

    Sicily, Messina
    Italy

    Site Not Available

  • Clinical Trial Site

    Bologna,
    Italy

    Site Not Available

  • Clinical Trial Site

    Messina,
    Italy

    Site Not Available

  • Clinical Trial Site

    Pavia,
    Italy

    Site Not Available

  • Clinical Trial Site

    Barcelona, 8907
    Spain

    Site Not Available

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    Madrid,
    Spain

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  • Clinical Trial Site

    Umea,
    Sweden

    Site Not Available

  • Clinical Trial Site

    Croydon, England
    United Kingdom

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    London, England
    United Kingdom

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  • Clinical Trial Site

    Tooting,
    United Kingdom

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    Bakersfield, California
    United States

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    Beverly Hills, California
    United States

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  • Clinical Trial Site

    La Mesa, California
    United States

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    Los Angeles, California
    United States

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    San Diego, California
    United States

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    San Francisco, California
    United States

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    Stanford, California
    United States

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  • Clinical Trial Site

    Torrance, California
    United States

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    Aurora, Colorado
    United States

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  • Clinical Trial Site

    Washington, District of Columbia 20037
    United States

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  • Clinical Trial Site

    Washington, D.C., District of Columbia 20422
    United States

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    Tampa, Florida
    United States

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    Atlanta, Georgia
    United States

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    Chicago, Illinois 60637
    United States

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    New Orleans, Louisiana
    United States

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    Baltimore, Maryland 21201
    United States

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  • Clinical Trial Site

    Boston, Massachusetts 02111
    United States

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    Detroit, Michigan
    United States

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    Rochester, Minnesota
    United States

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    Saint Louis, Missouri
    United States

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    St. Louis, Missouri
    United States

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    Newark, New Jersey
    United States

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    Bronx, New York
    United States

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    New York, New York
    United States

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    New York City, New York
    United States

    Site Not Available

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    Rosedale, New York
    United States

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    The Bronx, New York
    United States

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    Durham, North Carolina
    United States

    Site Not Available

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    Cleveland, Ohio 44195
    United States

    Site Not Available

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    Columbus, Ohio
    United States

    Site Not Available

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    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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    Charleston, South Carolina
    United States

    Site Not Available

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    Nashville, Tennessee
    United States

    Site Not Available

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    Dallas, Texas
    United States

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    Fort Worth, Texas
    United States

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    Houston, Texas
    United States

    Site Not Available

  • Clinical Trial Site

    Richmond, Virginia
    United States

    Site Not Available

  • Clinical Trial Site

    Seattle, Washington
    United States

    Site Not Available

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