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TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy
TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy

NCT07223203

RecruitingPhase 3

Sponsor: Alnylam Pharmaceuticals

Conditions: Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy, hATTR-PN

Interventions: Nucresiran, Vutrisiran

Countries: United States, Australia, Brazil, Cyprus, France, Germany, Greece, Italy

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, and gait speed * Demonstrate superiority of nucresiran compared to in-study vutrisiran with respect to serum transthyretin (TTR) levels

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (41)
  • Aurora, Colorado, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Darlinghurst, Australia
  • Woolloongabba, Australia
  • Ribeirão Preto, Brazil
  • São Paulo, Brazil
  • Égkomi, Cyprus
  • Créteil, France
  • Le Kremlin-Bicêtre, France
  • Marseille, France
  • Berlin, Germany
  • Münster, Germany
  • Athens, Greece
  • Heraklion, Greece
  • Florence, Italy
  • Milan, Italy
  • Pavia, Italy
  • Roma, Italy
  • Kumamoto, Japan
  • Suita, Japan
  • Kuala Lumpur, Malaysia
  • Lisbon, Portugal
  • Porto, Portugal
  • + 11 more on CT.gov