ATTR Expanded Access Program (EAP) by Ionis

Last updated: August 1, 2019
Sponsor: Ionis Pharmaceuticals, Inc.
Overall Status: Planned

Phase

N/A

Condition

Amyloidosis

Treatment

N/A

Clinical Study ID

NCT03400098
ISIS 420915-CS5
  • Ages > 18
  • All Genders

Study Summary

The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female at least 18 years of age with a diagnosis of hATTR

  • Symptoms consistent with polyneuropathy

  • Meet Polyneuropathy Disability (PND) Stage I-III requirements

Exclusion

Exclusion Criteria:

  • Known Primary Amyloidosis, Leptomeningeal Amyloidosis or Monoclonal Gammopathy ofUndetermined Significance or Multiple Myeloma

  • Have inadequate cardiac function

  • Have low platelet counts

  • Have inadequate renal function

Study Design

Study Start date:
Estimated Completion Date:

Study Description

The Program is intended to provided expanded access to Inotersen for eligible patients with hATTR who have limited or no available treatment options.

Connect with a study center

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • University of California - Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of California - Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • SC3 Research - Pasadena

    Pasadena, California 91105
    United States

    Site Not Available

  • University of California - San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • University of North Carolina - Chapel Hill, Department of Neurology

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Oregon Health and Science University, Knight Cardiovascular Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Penn Presbyterian Medical Center - University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Physicians, Department of Neurology

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah 84103
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.