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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

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