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

Phase 3TerminatedNCT02465203

Novartis Pharmaceuticals105 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

105

Conditions

Hepatitis C, Chronic

Interventions

Previous treatment in DEB025 studyDRUG

Follow-up after DEB025 active study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

HCV RNA Sequencing

Persistence of resistance associated variants

Time frame: 27 months

Secondary Outcomes

Safety Parameters as Measured by HCV RNA Sequencing

Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro

Time frame: 27 months

Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters

Changes in liver function and disease over time

Time frame: 27 months

Safety Parameters as Measured by Liver UltraSound and Lab Parameters

Development of hepatocellular carcinoma (HCC)

Time frame: 27 months

Safety Parameters

Safety over time of previous alisporivir exposure

Time frame: 27 months

Data from ClinicalTrials.gov

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Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Ventura, California, United States

Novartis Investigative Site

Honolulu, Hawaii, United States

Novartis Investigative Site

Springfield, Illinois, United States

Novartis Investigative Site

Arlington, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

San Antonio, Texas, United States

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Torono, Ontario, Canada

...and 30 more locations