A 3-year follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response

Conditions: Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.
MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-006131-38-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

-Written informed consent must be obtained before any assessment is performed -Males or females must be aged 18 years or older -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir -Have achieved SVR24 -Be able to comply with visit schedule
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 1300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer XML File Identifier: K6aU06lo1HleGgyLeCoFO4OY2Zs= Page 10/20 -Use or planned use to start a new course of hepatitis C therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartissponsored chronic Hepatitis C study.;Secondary Objective: -To determine whether subsequent detection of HCV RNA in patients who relapse following SVR24, represents the re-emergence of preexisting virus, the development of resistance mutations, or whether it is due to re-infection. -To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC). -To assess the safety over time of previous alisporivir exposure.;Primary end point(s): To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point.;Timepoint(s) of evaluation of this end point: During the 5 scheduled visits within three years.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -HCV RNA viral load -The proportion of patients who normalize alanine aminotransferase (ALT) -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The proportion of relapsed patients -The proportion of re-infected patients -The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations;Timepoint(s) of evaluation of this end point: During the 5 scheduled visits within three years.