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Recruiting Phase 3 NCT07052903

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Phase 3 – large-scale trial before approval
Conditions: Transthyretin Amyloidosis With Cardiomyopathy

Sponsor: Alnylam Pharmaceuticals

trial.available_in: БГ
Overview
The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Who can participate
Inclusion Criteria * Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis. * Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic. * Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>300 ng/L and \<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \>600 ng/L and \<8500 ng/L. * Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator. Exclusion Criteria * Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3. * Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV. * Has an estimated glomerular filtration rate eGFR of \<30 mL/min/1.73m\^2 at screening. * Has received prior or currently receiving TTR-lowering therapy
Locations 29
Argentina (1)
Clinical Trial Site
Buenos Aires
Australia (1)
Clinical Trial Site
Adelaide
Belgium (1)
Clinical Trial Site
Aalst
Brazil (1)
Clinical Trial Site
Belo Horizonte
Canada (1)
Clinical Trial Site
London
Chile (1)
Clinical Trial Site
Santiago
China (1)
Clinical Trial Site
Dongcheng
Czech Republic (1)
Clinical Trial Site
Brno
Denmark (1)
Clinical Trial Site
Aarhus N
France (1)
Clinical Trial Site
Chambray-lès-Tours
Greece (1)
Clinical Trial Site
Athens
Hong Kong (1)
Clinical Trial Site
Hong Kong
Hungary (1)
Clinical Trial Site
Budapest
Israel (1)
Clinical Trial Site
Be’er Ya‘aqov
Italy (1)
Clinical Trial Site
Ancona
Japan (1)
Clinical Trial Site
Bunkyō City
Malaysia (1)
Clinical Trial Site
Kajang
Netherlands (1)
Clinical Trial Site
Eindhoven
New Zealand (1)
Clinical Trial Site
Christchurch
Norway (1)
Clinical Trial Site
Ålesund
Portugal (1)
Clinical Trial Site
Carnaxide
Romania (1)
Clinical Trial Site
Bucharest
Slovakia (1)
Clinical Trial Site
Košice
South Korea (1)
Clinical Trial Site
Incheon
Spain (1)
Clinical Trial Site
A Coruña
Sweden (1)
Clinical Trial Site
Gothenburg
Taiwan (1)
Clinical Trial Site
New Taipei City
United Kingdom (1)
Clinical Trial Site
Bellshill
United States (1)
Clinical Trial Site
La Jolla , California
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
02.07.2025
Completion date
30.11.2032
Registry ID
NCT07052903
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.