A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studies

Conditions: Chronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.
MedDRA version: 14.1Level: PTClassification code 10008909Term: Chronic hepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-006132-24-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

-Written informed consent must be obtained before any assessment is performed -Males or females aged 18 or greater -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent -Have not acheived SVR24
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer -Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the persistence of resistance associated variants associated with failure to previous alisporivir therapy.;Secondary Objective: -To perform phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro -To monitor the changes in liver function and disease over time -To assess the development of hepatocellular carcinoma (HCC) -To assess the safety over time of previous alisporivir exposure;Primary end point(s): Time to reversion to wild-type for subjects who had genotypic change (resistance associated variants) in the feeder study.;Timepoint(s) of evaluation of this end point: During 11 scheduled visits within three years according to the assessment schedule

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -HCV RNA viral load -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The assessment of safety will be based on the analyses of adverse events, vital signs and laboratory evaluations;Timepoint(s) of evaluation of this end point: During 11 scheduled visits within three years according to the assessment schedule