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NCT02465203 Clinical Trial

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

Hepatitis C, Chronic Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02465203
Other study ID # CDEB025A2313
Secondary ID 2011-006132-24
Status Terminated
Phase Phase 3
First received March 17, 2015
Last updated December 13, 2017
Start date September 6, 2012
Est. completion date January 23, 2014

Study information
Verified date December 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 105
Est. completion date January 23, 2014
Est. primary completion date January 23, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Previous treatment in DEB025 study
Follow-up after DEB025 active study

Locations
Country Name City State
Australia Novartis Investigative Site Westmead New South Wales
Belgium Novartis Investigative Site Leuven
Canada Novartis Investigative Site Torono Ontario
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Koeln Nordrhein-Westfalen
Hungary Novartis Investigative Site Budapest
India Novartis Investigative Site Mumbai Maharashtra
Italy Novartis Investigative Site Parma PR
Italy Novartis Investigative Site Pavia PV
Italy Novartis Investigative Site Roma RM
Italy Novartis Investigative Site Torino TO
Korea, Republic of Novartis Investigative Site Busan
Korea, Republic of Novartis Investigative Site Pusan
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Warszawa
Puerto Rico Novartis Investigative Site San Juan
Romania Novartis Investigative Site Bucharest District 1
Romania Novartis Investigative Site Bucharest District 3
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Iasi
Spain Novartis Investigative Site Barcelona Catalunya
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Lin-Kou
Taiwan Novartis Investigative Site Taichung
Taiwan Novartis Investigative Site Yun-Lin
Thailand Novartis Investigative Site Songkla
United States Novartis Investigative Site Arlington Texas
United States Novartis Investigative Site Honolulu Hawaii
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site Springfield Illinois
United States Novartis Investigative Site Ventura California
Vietnam Novartis Investigative Site Ho Chi Minh

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Australia,  Belgium,  Canada,  Germany,  Hungary,  India,  Italy,  Korea, Republic of,  Poland,  Puerto Rico,  Romania,  Spain,  Taiwan,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary HCV RNA Sequencing Persistence of resistance associated variants 27 months
Secondary Safety Parameters as Measured by HCV RNA Sequencing Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro 27 months
Secondary Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters Changes in liver function and disease over time 27 months
Secondary Safety Parameters as Measured by Liver UltraSound and Lab Parameters Development of hepatocellular carcinoma (HCC) 27 months
Secondary Safety Parameters Safety over time of previous alisporivir exposure 27 months
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