Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

June 30, 2016 updated by: Debiopharm International SA

A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1

This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, v6z 2k5
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V5Z 1J4
        • Novartis Investigative Site
  • France
      • Clichy, France, 92110
        • Novartis Investigative Site
      • Creteil, France, 94000
        • Novartis Investigative Site
      • Paris, France, 75006
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Berlin, Germany, 10969
        • Novartis Investigative Site
      • Berlin, Germany, 10969
        • Novartis Investigational site
      • Duesseldorf, Germany, 40225
        • Novartis Investigative Site
      • Düsseldorf, Germany, 40237
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Frieburg, Germany, 79106
        • Novartis Investigational site
      • Hamburg, Germany, 20099
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Kiel, Germany, 24146
        • Novartis Investigative Site
      • Koln, Germany, 50924
        • Novartis Investigational site
      • Köln, Germany, 50924
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigational site
  • Italy
      • Bologna, Italy, 40138
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20122
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41124
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Novartis Investigative Site
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
    • Madrid
      • Majadanonda, Madrid, Spain, 28222
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, NW3 3QG
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Novartis Investigative Site
    • California
      • Bakersfield, California, United States, 93301
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90033
        • Novartis Investigative Site
      • Palo Alto, California, United States, 95128
        • Novartis Investigative Site
      • Sacramento, California, United States, 95817
        • Novartis Investigative Site
      • San Diego, California, United States, 92114
        • Novartis Investigative Site
      • San Diego, California, United States, 92128
        • Novartis Investigative Site
      • Ventura, California, United States, 93003
        • Novartis Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Novartis Investigative Site
      • Bradenton, Florida, United States, 34209
        • Novartis Investigational site
      • Miami, Florida, United States, 33136
        • Novartis Investigative Site
      • Wellington, Florida, United States, 33414
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novartis Investigative Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10029
        • Novartis Investigative Site
      • New York, New York, United States, 10032
        • Novartis Investigative Site
      • New York, New York, United States, 10021
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75246
        • Novartis Investigative Site
    • Virginia
      • Alexandria, Virginia, United States, 22306
        • Novartis Investigative Site
      • Newport News, Virginia, United States, 23602
        • 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure
  2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Exclusion criteria:

  1. Use of other investigational drugs at the time of enrollment
  2. History of hypersensitivity to PEG or RBV
  3. Any null non-responders to prior PEG/RBV treatment

Other protocol-defined inclusion/exclusion criteria may apply.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
Drug: Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Other Names:
  • Pegasys®
Drug: Ribavirin
RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Other Names:
  • Copegus®
  • RBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
Time Frame: 12 weeks posttreatment
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
12 weeks posttreatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
Time Frame: 24 weeks posttreatment
SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
24 weeks posttreatment
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Time Frame: 12 weeks posttreatment
Level of detection (LOD) was defined as 10 IU/mL
12 weeks posttreatment
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time Frame: 48 weeks
48 weeks

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

March 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 23, 2011

First Submitted That Met QC Criteria

December 27, 2011

First Posted (Estimate)

December 28, 2011

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDEB025A2306
  • 2011-004653-31 (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.

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