Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Alisporivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: From Study 2210<br>All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. | Drug: Alisporivir<br>* Intervention of interest; follow-up after ALV-active study<br>* Other names: ALV;|
| Experimental: From Study 2301<br>All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. | Drug: Alisporivir<br>* Intervention of interest; follow-up after ALV-active study<br>* Other names: ALV;|
| Experimental: From Study 2211<br>All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study. | Drug: Alisporivir<br>* Intervention of interest; follow-up after ALV-active study<br>* Other names: ALV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 |  | up to 120 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. | Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir. | at Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C