ATTR Expanded Access Program (EAP) by Ionis

N/AApproved For MarketingNCT03400098

Ionis Pharmaceuticals, Inc.

Overview

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

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

Conditions

Amyloidosis, Hereditary

Interventions

InotersenDRUG

Inotersen administered by subcutaneous (SC) injections in the abdomen, thigh, or upper arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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