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TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy
Sponsor: Alnylam Pharmaceuticals
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, and gait speed * Demonstrate superiority of nucresiran compared to in-study vutrisiran with respect to serum transthyretin (TTR) levels
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2025-12-12
Completion Date
2031-06-12
Last Updated
2026-05-14
Healthy Volunteers
No
Interventions
Nucresiran
Nucresiran 300 mg administered SC q6M
Vutrisiran
Vutrisiran 25 mg administered SC q3M
Locations (16)
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
São Paulo, Brazil
Clinical Trial Site
Le Kremlin-Bicêtre, France
Clinical Trial Site
Florence, Italy
Clinical Trial Site
Milan, Italy
Clinical Trial Site
Suita, Japan
Clinical Trial Site
Kuala Lumpur, Malaysia
Clinical Trial Site
Porto, Portugal
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Stockholm, Sweden
Clinical Trial Site
Umeå, Sweden
Clinical Trial Site
Taipei, Taiwan
Clinical Trial Site
Taoyuan City, Taiwan