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RECRUITINGPhase 3INTERVENTIONAL

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

TRITON-PN: A Phase 3, Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy (hATTR-PN)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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% Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Nucresiran

Nucresiran 300 mg administered SC q6M

DRUG

Vutrisiran

Vutrisiran 25 mg administered SC q3M

Locations (1)

Clinical Trial Site
Boston, Massachusetts, United States