A long term follow-up study of chronic hepatitis C patients treated withalisporivir to assess durability of sustained virologic response

Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]
MedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.

Registration Number: EUCTR2011-006131-38-PL

Lead Sponsor: ovartis Pharma Services AG

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 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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

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 Novartis-sponsored chronic Hepatitis C study.;Secondary Objective: <br>-To assess the impact of successful alisporivir treatment on the change<br>in liver disease over time and to assess the development of<br>hepatocellular carcinoma (HCC).<br>-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<br>-The proportion of patients who normalize alanine aminotransferase (ALT)<br>-Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen<br>-The proportion of relapsed patients<br>-The proportion of re-infected patients<br>-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.