Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

August 5, 2016 updated by: Debiopharm International SA

A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1081

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
      • Cordoba, Argentina, X5004BAL
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2002KDS
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Novartis Investigative Site
      • 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
      • Brussel, Belgium, 1090
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, v6z 2k5
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V5Z 1J4
        • Novartis Investigative Site
    • Ontario
      • Downsview, Ontario, Canada, M3N 2Z9
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 4G5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Novartis Investigative Site
  • France
      • Clichy, France, 92110
        • Novartis Investigative Site
      • Grenoble, France, 38043
        • Novartis Investigative Site
      • Lyon Cedex 04, France, 69317
        • Novartis Investigative Site
      • Toulouse cedex 9, France, 31059
        • Novartis Investigative Site
      • Villejuif, France, 94805
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Berlin, Germany, 10969
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • 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
      • Köln, 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
      • Hongkong, 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
  • Italy
      • Bologna, Italy, 40138
        • Novartis Investigative Site
      • Napoli, Italy, 80135
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • 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
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RM
      • 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
    • Gyeongsangnam-Do
      • Yangsan-si, Gyeongsangnam-Do, Korea, Republic of, 626-770
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 03722
        • Novartis Investigative Site
    • Kyeonggi
      • Kyunggi, Kyeonggi, Korea, Republic of, 463-712
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • México, Distrito Federal, Mexico, 14000
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-540
        • Novartis Investigative Site
      • Bydgoszcz, Poland, 85-030
        • Novartis Investigative Site
      • Chorzów, Poland, 41-500
        • Novartis Investigative Site
      • Kielce, Poland, 25-317
        • Novartis Investigative Site
      • Lódz, Poland, 91-347
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 020125
        • Novartis Investigative Site
      • Cluj Napoca, Romania, 400006
        • Novartis Investigative Site
      • Craiova, Romania, 200515
        • 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
    • Jud. Iasi
      • Iasi, Jud. Iasi, Romania, 700111
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 111123
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119333
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119992
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127473
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 194044
        • Novartis Investigative Site
      • St.- Petersburg, Russian Federation, 197376
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28029
        • Novartis Investigative Site
    • 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
      • Niaosong Township, Taiwan, 83301
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Yun-Lin, Taiwan, 640
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • 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
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • 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
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novartis Investigative Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Novartis Investigative Site
      • Oakland, California, United States, 94612
        • Novartis Investigative Site
      • San Diego, California, United States, 92123
        • Novartis Investigative Site
      • San Diego, California, United States, 92101
        • 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
      • Maitland, Florida, United States, 32751
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33607
        • Novartis Investigative Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Novartis Investigative Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novartis Investigative Site
      • Baltimore, Maryland, United States, 21202
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • Novartis Investigative Site
      • St. Louis, Missouri, United States, 63110
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Novartis Investigative Site
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Novartis Investigative Site
    • New York
      • Brooklyn, New York, United States, 11230
        • Novartis Investigative Site
      • New York, New York, United States, 10016
        • Novartis Investigative Site
      • New York, New York, United States, 10021
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Novartis Investigative Site
      • Fayetteville, North Carolina, United States, 28304
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75390
        • 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
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Novartis Investigative Site
      • Newport News, Virginia, United States, 23602
        • Novartis Investigative Site
  • Vietnam
      • 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Chronic HCV infection
  • HCV genotype 1
  • No previous treatment for hepatitis C infection
  • Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
  • Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

Exclusion criteria:

  • HCV genotype different from genotype 1 or co-infection with other HCV genotype
  • Co-infection with Hepatitis B or HIV
  • Any other cause of relevant liver disease other than HCV
  • Presence or history of hepatic decompensation
  • Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (> ULN) in past 6 months

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm A

Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):

  • Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks
  • Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
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
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
Experimental: Treatment Arm B
Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
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
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
Experimental: Treatment Arm C
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
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
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
Active Comparator: Treatment Arm D
ALV Placebo with PEG and RBV for 48 weeks
Drug: Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Other Names:
  • Pegasys®
  • PEG
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
Drug: ALV Placebo
ALV placebo soft gel capsules administered orally
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

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 after the end of treatment
SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.
24 weeks after the end of treatment
Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
Time Frame: after 4 weeks of treatment
RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.
after 4 weeks of treatment
Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
Time Frame: after 12 weeks of treatment
EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.
after 12 weeks of treatment
Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
Time Frame: after 12 weeks of treatment
pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.
after 12 weeks of treatment
Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
Time Frame: after 12 weeks of treatment
cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.
after 12 weeks of treatment
Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
Time Frame: from 4 to 12 weeks of treatment
eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.
from 4 to 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
Time Frame: at treatment end within 48 weeks
ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).
at treatment end within 48 weeks
Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
Time Frame: within 48 weeks

ALT abnormalities were summarized as participants who had either:

  • ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
  • ALT > 3 x ULN during the study and > 2 x ULN at baseline
within 48 weeks
Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
Time Frame: within 48 weeks

Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).

Participants with multiple abnormalities were counted only once in the worst category.
within 48 weeks
Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
Time Frame: within 48 weeks
Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
within 48 weeks
Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
Time Frame: within 48 weeks
Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
within 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, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 18, 2011

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDEB025A2301
  • 2010-022867-37 (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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