Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

July 14, 2016 updated by: Debiopharm International SA

A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

723

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

  • Argentina
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1405BCK
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Novartis Investigative Site
      • Kogarah, New South Wales, Australia, 2217
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Novartis Investigative Site
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, v6z 2k5
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V5Z 1J4
        • Novartis Investigative Site
    • Ontario
      • Torono, Ontario, Canada, M5G 2C4
        • Novartis Investigative Site
  • France
      • Clichy, France, 92110
        • Novartis Investigative Site
      • Creteil, France, 94010
        • Novartis Investigative Site
      • Lyon Cedex 04, France, 69317
        • Novartis Investigative Site
      • Nice Cedex 3, France, 06202
        • Novartis Investigative Site
      • Paris, France, 75014
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10969
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • 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
      • Koeln, Germany, 50937
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Bekescsaba, Hungary, H-5600
        • Novartis Investigative Site
      • Budapest, Hungary, 1083
        • Novartis Investigative Site
      • Budapest, Hungary, 1097
        • Novartis Investigative Site
      • Budapest, Hungary, 1126
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Kaposvár, Hungary, 7400
        • Novartis Investigative Site
      • Pecs, Hungary, 7624
        • Novartis Investigative Site
      • Szekesfehervar, Hungary, 8000
        • Novartis Investigative Site
  • India
      • Delhi, India, 110070
        • Novartis Investigative Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500012
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy, 40138
        • Novartis Investigative Site
      • Napoli, Italy, 80135
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20162
        • Novartis Investigative Site
      • Milano, MI, Italy, 20122
        • Novartis Investigative Site
      • Milano, MI, Italy, 20121
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
      • Roma, RM, Italy, 00133
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Novartis Investigative Site
      • Busan, Korea, Republic of, 602-715
        • Novartis Investigative Site
      • Incheon, Korea, Republic of, 22332
        • Novartis Investigative Site
      • Pusan, Korea, Republic of, 614-735
        • Novartis Investigative Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
        • Novartis Investigative Site
    • Gyeongsangnam-Do
      • Yangsan-si, Gyeongsangnam-Do, Korea, Republic of, 626-770
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 03722
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • México, Distrito Federal, Mexico, 14000
        • Novartis Investigative Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64020
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-540
        • Novartis Investigative Site
      • Bydgoszcz, Poland, 85-030
        • Novartis Investigative Site
      • Lódz, Poland, 91-347
        • Novartis Investigative Site
      • Warszawa, Poland, 01-201
        • Novartis Investigative Site
      • Zawiercie, Poland, 42-400
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 021105
        • Novartis Investigative Site
      • Bucharest, Romania, 030317
        • Novartis Investigative Site
      • Bucharest, Romania, 020125
        • Novartis Investigative Site
      • Bucharest, Romania, 050524
        • Novartis Investigative Site
      • Craiova, Romania, 200515
        • Novartis Investigative Site
      • Iasi, Romania, 700506
        • Novartis Investigative Site
      • Iasi, Romania
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 111123
        • Novartis Investigative Site
      • St.- Petersburg, Russian Federation, 197376
        • Novartis Investigative Site
  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain, 41014
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08003
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Novartis Investigative Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Novartis Investigative Site
  • Taiwan
      • Chia-Yi, Taiwan, 600
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 807
        • Novartis Investigative Site
      • Keelung City, Taiwan, 20401
        • Novartis Investigative Site
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Niaosong Township, Taiwan, 83301
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 112
        • Novartis Investigative Site
      • Yun-Lin, Taiwan, 640
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
      • Khon Kaen, Thailand, 40002
        • Novartis Investigative Site
      • Songkla, Thailand, 90110
        • Novartis Investigative Site
  • Turkey
      • Fatih / Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • Novartis Investigative Site
      • Glasgow - Scotland, United Kingdom, G12 OYN
        • Novartis Investigative Site
      • London, United Kingdom, SW17 0QT
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novartis Investigative Site
      • Plymouth, United Kingdom, PL6 8DH
        • Novartis Investigative Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Novartis Investigative Site
      • San Diego, California, United States, 92101
        • Novartis Investigative Site
      • Ventura, California, United States, 93003
        • Novartis Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novartis Investigative Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75246-2096
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78215
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site
      • Hanoi, Vietnam
        • Novartis Investigative Site
      • 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. Provides written informed consent before any assessment is performed
  2. Is male or female aged ≥18
  3. Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
  4. Has achieved SVR24
  5. Is able to comply with the visit schedule

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. Use or planned use to start a new course of hepatitis C therapy.
  3. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

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

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: From Study 2210
All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Drug: Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Names:
  • DEB025
  • ALV
  • Debio 025
Experimental: From Study 2301
All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Drug: Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Names:
  • DEB025
  • ALV
  • Debio 025
Experimental: From Study 2211
All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Drug: Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Names:
  • DEB025
  • ALV
  • Debio 025

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Time Frame: up to 120 Weeks
up to 120 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.
Time Frame: at Week 48
Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.
at Week 48

Collaborators and Investigators

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

Sponsor

Debiopharm International SA

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

December 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDEB025A2312
  • 2011-006131-38 (EudraCT Number)

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.

Clinical Trials on Hepatitis C

Clinical Trials on Alisporivir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe