CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 723 enrolled
Drug / intervention
Alisporivirdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02753699
NCT02753699Phase 3Completed
CompareCT.gov

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

Debiopharm International SA·interventional·Posted Apr 28, 2016·Updated Aug 26, 2016

In Brief

A Phase 3 clinical trial evaluating Alisporivir for Hepatitis C. Completed, enrolled 723 participants across 119 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesArgentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, Poland, Romania, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

Alisporivirdrug

Intervention of interest; follow-up after ALV-active study