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

What's the purpose of 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

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 3

Enrollment: 125 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Boston Medical Center

Boston, MA

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting
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