3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
Primary Purpose
Hepatitis C, Chronic
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Previous treatment in DEB025 study
Sponsored by

About this trial
This is an interventional other trial for Hepatitis C, Chronic focused on measuring Hepatitis C, chronic
Eligibility Criteria
Inclusion Criteria:
- Males or females aged ≥18
- Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
- Have not achieved SVR24
Exclusion Criteria:
- Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
- Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Follow up from feeder studies
Arm Description
Follow up arm
Outcomes
Primary Outcome Measures
HCV RNA Sequencing
Persistence of resistance associated variants
Secondary Outcome Measures
Safety Parameters as Measured by HCV RNA Sequencing
Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters
Changes in liver function and disease over time
Safety Parameters as Measured by Liver UltraSound and Lab Parameters
Development of hepatocellular carcinoma (HCC)
Safety Parameters
Safety over time of previous alisporivir exposure
Full Information
NCT ID
NCT02465203
First Posted
March 17, 2015
Last Updated
December 13, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02465203
Brief Title
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was prematurely terminated.
Study Start Date
September 6, 2012 (Actual)
Primary Completion Date
January 23, 2014 (Actual)
Study Completion Date
January 23, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, chronic
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Follow up from feeder studies
Arm Type
Other
Arm Description
Follow up arm
Intervention Type
Drug
Intervention Name(s)
Previous treatment in DEB025 study
Other Intervention Name(s)
Data was not collected
Intervention Description
Follow-up after DEB025 active study
Primary Outcome Measure Information:
Title
HCV RNA Sequencing
Description
Persistence of resistance associated variants
Time Frame
27 months
Secondary Outcome Measure Information:
Title
Safety Parameters as Measured by HCV RNA Sequencing
Description
Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Time Frame
27 months
Title
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters
Description
Changes in liver function and disease over time
Time Frame
27 months
Title
Safety Parameters as Measured by Liver UltraSound and Lab Parameters
Description
Development of hepatocellular carcinoma (HCC)
Time Frame
27 months
Title
Safety Parameters
Description
Safety over time of previous alisporivir exposure
Time Frame
27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females aged ≥18
Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
Have not achieved SVR24
Exclusion Criteria:
Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Novartis Investigative Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novartis Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Novartis Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Torono
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Novartis Investigative Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 036
Country
India
Facility Name
Novartis Investigative Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Pusan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 1
ZIP/Postal Code
050524
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 3
ZIP/Postal Code
030317
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700506
Country
Romania
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Kou
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Yun-Lin
ZIP/Postal Code
640
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Novartis Investigative Site
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
terminated
Learn more about this trial
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
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