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

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Alisporivir

• Registration Number: NCT02753699
• Lead Sponsor: Debiopharm International SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Results First Submitted: 2016-05-19
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-14
• Last Update Submitted: 2016-07-14
• Results First Posted: 2016-08-26
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 723

Inclusion Criteria

1. Provides written informed consent before any assessment is performed
2. Is male or female aged ≥18
3. Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
4. Has achieved SVR24
5. Is able to comply with the visit schedule

Exclusion Criteria

1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
2. Use or planned use to start a new course of hepatitis C therapy.
3. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
From Study 2210	Alisporivir	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.
From Study 2301	Alisporivir	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.
From Study 2211	Alisporivir	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam