NCT02753699

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 723 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Alisporivir	Intervention of interest; follow-up after ALV-active study

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2016-04-28
• Last updated: 2016-08-26
• Results posted: 2016-08-26

Locations

119 sites across 22 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, Poland, Romania, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam