ATTR Expanded Access Program (EAP) by Ionis

Description

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

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Drug: Inotersen

Study ID

Ionis Pharmaceuticals, Inc. -- ISIS 420915-CS5

Status

Available

Trial ID

NCT03400098

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Ionis Pharmaceuticals, Inc.

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 Criteria

  • Known Primary Amyloidosis, Leptomeningeal Amyloidosis or Monoclonal Gammopathy of Undetermined Significance or Multiple Myeloma
  • Have inadequate cardiac function
  • Have low platelet counts
  • Have inadequate renal function

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (22)

Study Location Distance Name Phone Email
The Neurological Institute at Columbia University Medical Center - New York, New York 44.8 miles None None None
Mount Sinai Medical Center - New York, New York 46.8 miles None None None
Penn Presbyterian Medical Center University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles None None None
Boston University Medical Center - Boston, Massachusetts 137.1 miles None None None
The Johns Hopkins Hospital - Baltimore, Maryland 219.6 miles None None None
Virginia Commonwealth University - Richmond, Virginia 339.5 miles None None None
University of Pittsburgh Physicians Department of Neurology - Pittsburgh, Pennsylvania 355.3 miles None None None
Cleveland Clinic - Cleveland, Ohio 439.5 miles None None None
University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center - Chapel Hill, North Carolina 482.1 miles None None None
Indiana University School of Medicine - Indianapolis, Indiana 686.4 miles None None None
Medical University of South Carolina - Charleston, South Carolina 691.2 miles None None None
Northwestern University - Evanston, Illinois 748.0 miles None None None
Vanderbilt University - Nashville, Tennessee 811.9 miles None None None
Washington University - Saint Louis, Missouri 922.3 miles None None None
MD Anderson - Houston, Texas 1,475.7 miles None None None
University of Utah Huntsman Cancer Institute - Salt Lake City, Utah 2,002.7 miles None None None
Mayo Clinic Cancer Center - Scottsdale, Arizona 2,164.9 miles None None None
Oregon Health and Science University Knight Cardiovascular Institute - Portland, Oregon 2,468.2 miles None None None
University of California Irvine - Irvine, California 2,480.1 miles None None None
CedarsSinai - Los Angeles, California 2,495.4 miles None None None
Stanford University - Palo Alto, California 2,599.9 miles None None None
University of California San Francisco - San Francisco, California 2,606.4 miles None None None

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