HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04153149Tipo: INTERVENTIONALInicio: 26 de nov de 2019Fin estimado: 2 de dic de 2026

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria
Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF

Criterios de exclusión

Has known primary amyloidosis or leptomeningeal amyloidosis
Has New York Heart Association (NYHA) Class IV heart failure
Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria
Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit
Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2
Has received prior TTR-lowering treatment
Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease

Intervenciones

drug

Vutrisiran

Vutrisiran will be administered by SC injection.

drug

Sterile Normal Saline (0.9% NaCl)

Sterile normal saline (0.9% NaCl) will be administered by SC injection.

Ubicaciones

Clinical Trial Site

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Clinical Trial Site

Buenos Aires, Pilar, Argentina

Clinical Trial Site

Buenos Aires, Argentina

Clinical Trial Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAlnylam Pharmaceuticals

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