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ATTR Expanded Access Program (EAP) by Ionis

Expanded Access Program for Inotersen (ISIS 420915) in Patients With Hereditary Transthyretin Amyloidosis (hATTR)

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03400098
Enrollment
Unknown
Registered
2018-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis, Hereditary

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.

Interventions

DRUGInotersen

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

Sponsors

Ionis Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026