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

Novartis

Status and phase: Terminated; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Previous treatment in DEB025 study

Study type: Interventional

Funder types: Industry

Identifiers

NCT02465203

CDEB025A2313

2011-006132-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Follow up from feeder studies

Other group

Description:

Follow up arm

Treatment:

Drug: Previous treatment in DEB025 study