A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

CompletadoFase 3ClinicalTrials.gov

ID: NCT02753699Tipo: INTERVENTIONALInicio: 1 de dic de 2011Fin estimado: 1 de may de 2015

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time. Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Criterios de exclusión

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

Intervenciones

drug

Alisporivir

Intervention of interest; follow-up after ALV-active study

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalDebiopharm International SA

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