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

December 13, 2017 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
  • Belgium
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Torono, Ontario, Canada, M5G 2C4
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Hamburg, Germany, 20099
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Kiel, Germany, 24146
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50937
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1097
        • Novartis Investigative Site
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 036
        • Novartis Investigative Site
  • Italy
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Novartis Investigative Site
      • Pusan, Korea, Republic of, 614-735
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-540
        • Novartis Investigative Site
      • Warszawa, Poland, 01-201
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 021105
        • Novartis Investigative Site
      • Bucharest, Romania, 020125
        • Novartis Investigative Site
      • Iasi, Romania, 700506
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Romania, 050524
        • Novartis Investigative Site
    • District 3
      • Bucharest, District 3, Romania, 030317
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 83301
        • Novartis Investigative Site
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Yun-Lin, Taiwan, 640
        • Novartis Investigative Site
  • Thailand
      • Songkla, Thailand, 90110
        • Novartis Investigative Site
  • United States
    • California
      • San Diego, California, United States, 92101
        • Novartis Investigative Site
      • Ventura, California, United States, 93003
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novartis Investigative Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78215
        • Novartis Investigative Site
  • Vietnam
      • Ho Chi Minh, Vietnam
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Follow up from feeder studies
Follow up arm
Drug: Previous treatment in DEB025 study
Follow-up after DEB025 active study
Other Names:
  • Data was not collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV RNA Sequencing
Time Frame: 27 months
Persistence of resistance associated variants
27 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2012

Primary Completion (Actual)

January 23, 2014

Study Completion (Actual)

January 23, 2014

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDEB025A2313
  • 2011-006132-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

terminated

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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