Status:
APPROVED_FOR_MARKETING
ATTR Expanded Access Program (EAP) by Ionis
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Amyloidosis, Hereditary
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03400098
Last Update
August 5 2019
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