3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
| Status: | Terminated |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/14/2018 |
| Start Date: | September 6, 2012 |
| End Date: | January 23, 2014 |
A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Patients
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24
in feeder studies
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.
achieved SVR24 to assess their viral activity, and to assess the changes in liver function
and disease, and post-treatment safety over time.
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
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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