An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Por invitaciónFase 3ClinicalTrials.gov

ID: NCT06679946Tipo: INTERVENTIONALInicio: 3 de dic de 2024Fin estimado: 31 de mar de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to obtain safety, efficacy, and pharmacodynamic data on the use of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy who continued on extended use of vutrisiran, or switched from patisiran.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003

Criterios de exclusión

Has permanently discontinued study drug administration while participating in the parent studies, ALN-TTR02-011, ALN-TTR02-014, or ALN-TTRSC02-003
Future or current participation in another investigational device or drug study, scheduled to occur during this study
Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation

Intervenciones

drug

Vutrisiran

Vutrisiran administered SC q3M

Ubicaciones

Clinical Trial Site

Buenos Aires, Argentina

Clinical Trial Site

Buenos Aires, Argentina

Clinical Trial Site

Buenos Aires, Argentina

Clinical Trial Site

Córdoba, Argentina

Clinical Trial Site

Rosario, Argentina

Clinical Trial Site

Rosario, Argentina

Clinical Trial Site

Rosario, Argentina

Patrocinadores

PrincipalAlnylam Pharmaceuticals

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