A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients
Overview
- Phase
- Phase 3
- Intervention
- Alisporivir
- Conditions
- Hepatitis C
- Sponsor
- Debiopharm International SA
- Enrollment
- 723
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
From Study 2210
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.
Intervention: Alisporivir
From Study 2301
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.
Intervention: Alisporivir
From Study 2211
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.
Intervention: Alisporivir
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Time Frame: up to 120 Weeks
Secondary Outcomes
- Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.(at Week 48)