Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

July 28, 2016 updated by: Boehringer Ingelheim

A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

678

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

  • Austria
      • Linz, Austria
        • 1220.7.4303 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1220.7.4301 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1220.7.4302 Boehringer Ingelheim Investigational Site
  • Belgium
      • Bruxelles, Belgium
        • 1220.7.3201 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 1220.7.3207 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 1220.7.3204 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1220.7.3205 Boehringer Ingelheim Investigational Site
      • Jette, Belgium
        • 1220.7.3206 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1220.7.3202 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1220.7.3203 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1220.7.1011 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1220.7.1012 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1220.7.1003 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1220.7.1016 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 1220.7.1007 Boehringer Ingelheim Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada
        • 1220.7.1004 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1220.7.1006 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1220.7.1010 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1220.7.1014 Boehringer Ingelheim Investigational Site
  • France
      • Clichy, France
        • 1220.7.3301 Boehringer Ingelheim Investigational Site
      • Lille, France
        • 1220.7.3311 Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1220.7.3303 Boehringer Ingelheim Investigational Site
      • Montpellier, France
        • 1220.7.3304 Boehringer Ingelheim Investigational Site
      • Nice Cedex 3, France
        • 1220.7.3305 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1220.7.3302 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1220.7.3310 Boehringer Ingelheim Investigational Site
      • Pessac Cedex, France
        • 1220.7.3316 Boehringer Ingelheim Investigational Site
      • Reims, France
        • 1220.7.3317 Boehringer Ingelheim Investigational Site
      • Rennes Cedex 09, France
        • 1220.7.3315 Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1220.7.3318 Boehringer Ingelheim Investigational Site
      • Vandoeuvre Cedex, France
        • 1220.7.3308 Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1220.7.4902 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1220.7.4904 Boehringer Ingelheim Investigational Site
      • Dortmund, Germany
        • 1220.7.4913 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Germany
        • 1220.7.4906 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Germany
        • 1220.7.4901 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1220.7.4908 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1220.7.4918 Boehringer Ingelheim Investigational Site
      • Herne, Germany
        • 1220.7.4907 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1220.7.4903 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1220.7.4911 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1220.7.4905 Boehringer Ingelheim Investigational Site
  • Japan
      • Chiba, Chiba, Japan
        • 1220.7.8106 Boehringer Ingelheim Investigational Site
      • Gifu, Gifu, Japan
        • 1220.7.8111 Boehringer Ingelheim Investigational Site
      • Itabashi-ku, Tokyo, Japan
        • 1220.7.8107 Boehringer Ingelheim Investigational Site
      • Izunokuni, Shizuoka, Japan
        • 1220.7.8112 Boehringer Ingelheim Investigational Site
      • Kamakura, Kanagawa, Japan
        • 1220.7.8108 Boehringer Ingelheim Investigational Site
      • Kita-gun, Kagawa, Japan
        • 1220.7.8117 Boehringer Ingelheim Investigational Site
      • Kofu, Yamanashi, Japan
        • 1220.7.8109 Boehringer Ingelheim Investigational Site
      • Kurashiki, Okayama, Japan
        • 1220.7.8116 Boehringer Ingelheim Investigational Site
      • Kurume, Fukuoka, Japan
        • 1220.7.8118 Boehringer Ingelheim Investigational Site
      • Matsumoto, Nagano, Japan
        • 1220.7.8110 Boehringer Ingelheim Investigational Site
      • Matsuyama, Ehime, Japan
        • 1220.7.8124 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1220.7.8113 Boehringer Ingelheim Investigational Site
      • Namegata, Ibaraki, Japan
        • 1220.7.8105 Boehringer Ingelheim Investigational Site
      • Nishinomiya, Hyogo, Japan
        • 1220.7.8114 Boehringer Ingelheim Investigational Site
      • Ogaki, Gifu, Japan
        • 1220.7.8125 Boehringer Ingelheim Investigational Site
      • Omura, Nagasaki, Japan
        • 1220.7.8119 Boehringer Ingelheim Investigational Site
      • Omuta, Fukuoka, Japan
        • 1220.7.8122 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1220.7.8121 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1220.7.8101 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japan
        • 1220.7.8102 Boehringer Ingelheim Investigational Site
      • Tanabe, Wakayama, Japan
        • 1220.7.8115 Boehringer Ingelheim Investigational Site
      • Toyama,Toyama, Japan
        • 1220.7.8123 Boehringer Ingelheim Investigational Site
      • Tsu, Mie, Japan
        • 1220.7.8126 Boehringer Ingelheim Investigational Site
      • Tsuchiura, Ibaraki, Japan
        • 1220.7.8104 Boehringer Ingelheim Investigational Site
  • Portugal
      • Aveiro, Portugal
        • 1220.7.3503 Boehringer Ingelheim Investigational Site
      • Barreiro, Portugal
        • 1220.7.3509 Boehringer Ingelheim Investigational Site
      • Coimbra, Portugal
        • 1220.7.3506 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1220.7.3501 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1220.7.3505 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 1220.7.3502 Boehringer Ingelheim Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico
        • 1220.7.0034 Boehringer Ingelheim Investigational Site
  • Spain
      • A Coruña, Spain
        • 1220.7.3406 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.7.3402 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.7.3404 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.7.3411 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1220.7.3412 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1220.7.3405 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1220.7.3409 Boehringer Ingelheim Investigational Site
      • Majadahonda-Madrid, Spain
        • 1220.7.3410 Boehringer Ingelheim Investigational Site
      • Santander, Spain
        • 1220.7.3408 Boehringer Ingelheim Investigational Site
      • Sevilla, Spain
        • 1220.7.3403 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1220.7.3401 Boehringer Ingelheim Investigational Site
      • Vigo (Pontevedra), Spain
        • 1220.7.3407 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Bern, Switzerland
        • 1220.7.4106 Boehringer Ingelheim Investigational Site
      • La Chaux-de-Fonds, Switzerland
        • 1220.7.4103 Boehringer Ingelheim Investigational Site
      • Lugano, Switzerland
        • 1220.7.4107 Boehringer Ingelheim Investigational Site
      • St. Gallen, Switzerland
        • 1220.7.4108 Boehringer Ingelheim Investigational Site
      • Zürich, Switzerland
        • 1220.7.4101 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bristol, United Kingdom
        • 1220.7.4405 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.7.4404 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.7.4409 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1220.7.4410 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1220.7.4401 Boehringer Ingelheim Investigational Site
      • Nottingham, United Kingdom
        • 1220.7.4408 Boehringer Ingelheim Investigational Site
      • Oxford, United Kingdom
        • 1220.7.4407 Boehringer Ingelheim Investigational Site
      • Southampton, United Kingdom
        • 1220.7.4403 Boehringer Ingelheim Investigational Site
  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States
        • 1220.7.0091 Boehringer Ingelheim Investigational Site
    • Colorado
      • Englewood, Colorado, United States
        • 1220.7.0082 Boehringer Ingelheim Investigational Site
    • Florida
      • Palm Harbor, Florida, United States
        • 1220.7.0095 Boehringer Ingelheim Investigational Site
    • Georgia
      • Columbus, Georgia, United States
        • 1220.7.0039 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1220.7.0013 Boehringer Ingelheim Investigational Site
    • Indiana
      • Vaiparaiso, Indiana, United States
        • 1220.7.0062 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • 1220.7.0085 Boehringer Ingelheim Investigational Site
      • Baton Rouge, Louisiana, United States
        • 1220.7.0087 Boehringer Ingelheim Investigational Site
      • New Orleans, Louisiana, United States
        • 1220.7.0101 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Framingham, Massachusetts, United States
        • 1220.7.0027 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1220.7.0012 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • 1220.7.0077 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 1220.7.0058 Boehringer Ingelheim Investigational Site
    • Texas
      • Arlington, Texas, United States
        • 1220.7.0063 Boehringer Ingelheim Investigational Site
      • Austin, Texas, United States
        • 1220.7.0029 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1220.7.0071 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1220.7.0009 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1220.7.0016 Boehringer Ingelheim Investigational 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:

  1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
  2. Confirmed prior virological failure with an approved dose of PegIFN/RBV
  3. Age 18 to 70 years,
  4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion criteria:

  1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
  3. Decompensated liver disease, or history of decompensated liver disease,
  4. Body weight < 40 or > 125 kg,
  5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
  6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
  7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
  8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men
  9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,

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
Active Comparator: Placebo/PegIFN/RBV
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
Drug: Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks
Drug: Placebo
Placebo to BI201335 for 24 weeks
Experimental: BI201335 12 weeks
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
Drug: Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks
Drug: BI 201335
BI 201335 once a day (QD) for 24 weeks
Experimental: BI201335 24 weeks
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
Drug: Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks
Drug: BI 201335
BI 201335 once a day (QD) for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Time Frame: 12 weeks post treatment, up to 60 weeks
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
12 weeks post treatment, up to 60 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Time Frame: 24 weeks post treatment, up to 72 weeks
Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)
Time Frame: Week 4 and Week 8
Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
Week 4 and Week 8
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
Time Frame: End of treatment, up to 48 weeks
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
Time Frame: End of treatment, up to 48 weeks
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
Time Frame: End of treatment, up to 48 weeks
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
Time Frame: End of treatment, up to 48 weeks
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Time Frame: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
Time Frame: 12 weeks post treatment, up to 60 weeks
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Time Frame: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
Time Frame: 12 weeks post treatment, up to 60 weeks
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
12 weeks post treatment, up to 60 weeks

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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.

Helpful Links

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

June 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (Estimate)

May 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1220.7
  • 2010-021715-17 (EudraCT Number: EudraCT)

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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