Status:
NOT_YET_RECRUITING
TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy
hATTR-PN
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to: * Determine the efficacy of nucresiran in patients with hATTR-PN by evaluating the effect on neurologic impairment, quality of life, nutritional status, disability, a...
Eligibility Criteria
Inclusion
- Has documented diagnosis of hATTR-PN
- Has a diagnosis of hATTR amyloidosis with polyneuropathy with a documented TTR gene variant
- Has a neuropathy impairment score (NIS) of 5 to 130 (inclusive)
- Has a Karnofsky Performance Status (KPS) of ≥60%
Exclusion
- Has had a liver transplant or is likely, in the opinion of the Investigator, to undergo liver transplantation during the Treatment Period of the study
- Has known other (non-hATTR) forms of amyloidosis or clinical evidence of leptomeningeal amyloidosis
- Has a New York Heart Association (NYHA) heart failure classification \>2
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN)
- Has total bilirubin \>1.5 ULN
- Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m\^2
- Has other known causes of sensorimotor or autonomic neuropathy
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2031
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07223203
Start Date
December 31 2025
End Date
June 12 2031
Last Update
December 22 2025
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