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)
A Clinical Research Study of Nucresiran for Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN)
Sponsor: Alnylam Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: ACYY0240
U.S. Govt. ID: NCT07223203
Contact: Jorge Cabrera, CRC: 2123056035 / jec2273@cumc.columbia.edu
Additional Study Information: TRITON-PN is a global Phase 3 randomized, open-label study designed to evaluate the Efficacy and Safety of Nucresiran in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy (hATTR-PN). The study will also evaluate any changes in quality of life experienced by study participants. Nucresiran is a TTR silencer that aims to prevent misfolded TTR proteins from being made, which may prevent further buildup in the nerves and potentially slow disease progression. During the study, participants will be assigned at random to receive either the investigational medication, nucresiran, or vutrisiran for hereditary ATTR amyloidosis with polyneuropathy. There is no placebo in this study. Study participants will have an 80% chance of receiving nucresiran, and a 20% chance of receiving vutrisiran. Total time in the study is up to 50 months. Study visits every 3 months (some will happen more often). Travel and accommodation support may be available, including the option of study visits provided at home by a home nursing specialist.
Investigator
Thomas Brannagan, MD
Do You Qualify?
Are you between 18 to 85 years of age? Yes No
Do you have hereditary ATTR amyloidosis (confirmed through genetic testing) with polyneuropathy? Yes No
Are you able to understand and willing and able to comply with the study requirements and to provide written informed consent? Yes No
Have you had a liver transplant or anticipated to have a liver transplant during the treatment period of the study? Yes No
Do you have a diagnosis of type I diabetes or type II diabetes for more than 5 years)? Yes No
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For more information, please contact:
Jorge Cabrera, CRC
jec2273@cumc.columbia.edu
2123056035