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ATTR Expanded Access Program (EAP) by Ionis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400098
Expanded Access Status : Approved for marketing
First Posted : January 17, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date January 8, 2018
First Posted Date January 17, 2018
Last Update Posted Date August 5, 2019
 
Descriptive Information
Brief Title ATTR Expanded Access Program (EAP) by Ionis
Brief Summary The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).
Detailed Description The Program is intended to provided expanded access to Inotersen for eligible patients with hATTR who have limited or no available treatment options.
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: Inotersen
Inotersen administered by subcutaneous (SC) injections in the abdomen, thigh, or upper arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT03400098
Responsible Party Ionis Pharmaceuticals, Inc.
Study Sponsor Ionis Pharmaceuticals, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Ionis Pharmaceuticals, Inc.
Verification Date August 2019