drugset / Trial / NCT02753699

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

NCT02753699

Phase 3 Completed 723 enrolled Debiopharm International SA
Non-randomizedSingle-groupOpen-label

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.

Timeline

Start
2011-12
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Background Alisporivir Protein / enzyme biologic