3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

Phase 3

Terminated

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Previous treatment in DEB025 study

• Registration Number: NCT02465203
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

Detailed Description

The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.

Study Timeline

• Study Start: 2012-09-06
• Primary Completion: 2014-01-23
• Study Completion: 2014-01-23
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Results First Submitted: 2015-07-15
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Results First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Males or females aged ≥18
2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
3. Have not achieved SVR24

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. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follow up from feeder studies	Previous treatment in DEB025 study	Follow up arm

Primary Outcome Measures

Name	Time	Method
HCV RNA Sequencing	27 months	Persistence of resistance associated variants

Secondary Outcome Measures

Name	Time	Method
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters	27 months	Changes in liver function and disease over time
Safety Parameters as Measured by HCV RNA Sequencing	27 months	Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Safety Parameters as Measured by Liver UltraSound and Lab Parameters	27 months	Development of hepatocellular carcinoma (HCC)
Safety Parameters	27 months	Safety over time of previous alisporivir exposure

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam