Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

July 20, 2016 updated by: Debiopharm International SA

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
      • 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 Center
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Fitzroy, Victoria, Australia, 3065
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M4V 1P7
        • Novartis Investigative Site
  • France
      • Clichy Cedex, France, 92118
        • Novartis Investigative Site
      • Creteil, France, 94000
        • Novartis Investigative Site
      • Marseille, France, 13008
        • Novartis Investigative Site
      • Paris, France, 75006
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10969
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Freiburg, Germany, 79095
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
  • India
      • Guwahati, India, 781006
        • Novartis Investigative Site
      • Haryana, India, 122001
        • Novartis Investigative Site
      • Hyderabad - Andhra Pradesh, India, 500012
        • Novartis Investigative Site
      • Mumbai, India, 400020
        • Novartis Investigative Site
      • New Delhi, India, 110070
        • Novartis Investigative Site
    • Kerala
      • Trivandrum, Kerala, India, 695607
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400036
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy, 40138
        • Novartis Investigative Site
      • Brescia, Italy, 25123
        • Novartis Investigative Site
      • Pavia, Italy, 27100
        • Novartis Investigative Site
      • Roma, Italy, 00133
        • Novartis Inestigative Site
      • Torino, Italy, 10126
        • Novartis Investigative Site
  • Korea, Republic of
      • Pusan, Korea, Republic of, 614-735
        • Novartis Investigative Site
      • Pusan, Korea, Republic of, 602-739
        • Novartis Inestigative Center
      • Seoul, Korea, Republic of, 738-736
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 120-752
        • Novartis Korea Ltd.
  • Poland
      • Bialystok, Poland, 15-540
        • Novartis Investigative Site
      • Lódz, Poland, 91-347
        • Novartis Investigative Site
      • Warsaw, Poland, 01 - 201
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Novartis Investigative Site
      • Niaosong Township, Taiwan, 83301
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, ROC112
        • Novartis Investigative Site
      • Yun-Lin, Taiwan
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
      • Songkla, Thailand, 90110
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow - Scotland, United Kingdom, G12 OYN
        • Novartis Investigative Site
      • London, United Kingdom, SW17 0QT
        • Novartis Investigative Site
      • London, United Kingdom, W2 1NY
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Novartis Investigative Site
      • Plymouth, United Kingdom, PL6 8DH
        • Novartis Investigative Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • San Diego, California, United States, 92101
        • Sharp Rees-Stealy Medical Group, Inc.
      • San Diego, California, United States, 92105
        • Research and Education Inc.
      • Ventura, California, United States, 93003
        • Island View Gastroenterology Associates
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawai Medical Center East LLC
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • The Office of Dr. Claudia Martorell
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Saint Louis University
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
    • Texas
      • Arlington, Texas, United States, 76012
        • The North Texas Research Institute
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas
      • Houston, Texas, United States, 77030
        • Liver Specialist of Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Chronic hepatitis C viral infection
  • Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
  • HCV genotype 2 or 3
  • No previous treatment for hepatitis C infection

Exclusion criteria:

  • Evidence of cirrhosis at the time of screening
  • Evidence of hepatocellular carcinoma at the time of screening
  • Any other cause of relevant liver disease other than HCV
  • Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALV 1000 mg
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV
Experimental: ALV 600 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV
Drug: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Names:
  • Copegus®
  • RBV
Experimental: ALV 800 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV
Drug: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Names:
  • Copegus®
  • RBV
Experimental: ALV 600 mg+PEG
Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
Drug: Alisporivir
ALV 200 mg soft gel capsules administered orally
Other Names:
  • DEB025
  • ALV
Drug: Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Other Names:
  • Pegasys®
  • PEG
Active Comparator: PEG+RBV
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Drug: Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Other Names:
  • Pegasys®
  • PEG
Drug: Ribavirin
RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Other Names:
  • Copegus®
  • RBV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
Time Frame: after 4 weeks of treatment
RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.
after 4 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
Time Frame: after 4 weeks of treatment
RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.
after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
Time Frame: after 4 weeks of treatment
after 4 weeks of treatment
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
Time Frame: after 4 weeks of treatment
after 4 weeks of treatment
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
Time Frame: after 12 weeks of treatment
cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.
after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
Time Frame: at end of treatment, within 24 weeks
ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.
at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
Time Frame: at end of treatment, within 24 weeks
at end of treatment, within 24 weeks
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
Time Frame: at end of treatment, within 24 weeks
at end of treatment, within 24 weeks
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
Time Frame: 12 weeks after the end of treatment
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.
12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
Time Frame: 12 weeks after the end of treatment
12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
Time Frame: 12 weeks after the end of treatment
12 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment
Percentage of Participants With On-treatment Viral Breakthrough
Time Frame: within 24 weeks of treatment

Viral breakthrough was defined as either:

  • Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
  • HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment
within 24 weeks of treatment
Percentage of Participants With Viral Relapse
Time Frame: within 24 weeks after the end of treatment
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.
within 24 weeks after the end of treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Debiopharm International SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDEB025A2211
  • 2010-020034-26 (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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