IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

March 17, 2016 updated by: Boehringer Ingelheim

A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

470

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
      • Graz, Austria
        • 1241.20.43003 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1241.20.01001 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1241.20.01008 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1241.20.01010 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 1241.20.01003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1241.20.01006 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1241.20.01002 Boehringer Ingelheim Investigational Site
      • Whitby, Ontario, Canada
        • 1241.20.01005 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1241.20.01007 Boehringer Ingelheim Investigational Site
  • France
      • Clermont-Ferrand Cedex, France
        • 1241.20.33003 Boehringer Ingelheim Investigational Site
      • Lyon, France
        • 1241.20.33004 Boehringer Ingelheim Investigational Site
      • Marseille Cedex 08, France
        • 1241.20.33006 Boehringer Ingelheim Investigational Site
      • Montpellier Cedex 5, France
        • 1241.20.33001 Boehringer Ingelheim Investigational Site
      • Nice Cedex 3, France
        • 1241.20.33005 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1241.20.33007 Boehringer Ingelheim Investigational Site
      • Pessac Cedex, France
        • 1241.20.33002 Boehringer Ingelheim Investigational Site
      • Rennes Cedex 09, France
        • 1241.20.33009 Boehringer Ingelheim Investigational Site
      • Vandoeuvre Cedex, France
        • 1241.20.33008 Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1241.20.49002 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1241.20.49004 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 1241.20.49012 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Germany
        • 1241.20.49001 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1241.20.49014 Boehringer Ingelheim Investigational Site
      • Herne, Germany
        • 1241.20.49009 Boehringer Ingelheim Investigational Site
      • Kiel, Germany
        • 1241.20.49008 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1241.20.49013 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1241.20.49011 Boehringer Ingelheim Investigational Site
      • Magdeburg, Germany
        • 1241.20.49006 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1241.20.49003 Boehringer Ingelheim Investigational Site
      • Oberhausen, Germany
        • 1241.20.49010 Boehringer Ingelheim Investigational Site
      • Ulm, Germany
        • 1241.20.49005 Boehringer Ingelheim Investigational Site
      • Würzburg, Germany
        • 1241.20.49007 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1241.20.36001 Boehringer Ingelheim Investigational Site
      • Kaposvar, Hungary
        • 1241.20.36002 Boehringer Ingelheim Investigational Site
  • Ireland
      • Dublin, Ireland
        • 1241.20.35301 Boehringer Ingelheim Investigational Site
      • Dublin, Ireland
        • 1241.20.35302 Boehringer Ingelheim Investigational Site
      • Dublin 8, Ireland
        • 1241.20.35303 Boehringer Ingelheim Investigational Site
  • Italy
      • Ancona, Italy
        • 1241.20.39007 Boehringer Ingelheim Investigational Site
      • Brescia, Italy
        • 1241.20.39003 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1241.20.39002 Boehringer Ingelheim Investigational Site
      • Milano, Italy
        • 1241.20.39008 Boehringer Ingelheim Investigational Site
      • Napoli, Italy
        • 1241.20.39006 Boehringer Ingelheim Investigational Site
      • Pavia, Italy
        • 1241.20.39005 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 1241.20.39001 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 1241.20.39004 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amsterdam, Netherlands
        • 1241.20.31001 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 1241.20.31003 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 1241.20.31004 Boehringer Ingelheim Investigational Site
      • Den Haag, Netherlands
        • 1241.20.31006 Boehringer Ingelheim Investigational Site
      • Groningen, Netherlands
        • 1241.20.31005 Boehringer Ingelheim Investigational Site
  • Portugal
      • Aveiro, Portugal
        • 1241.20.35103 Boehringer Ingelheim Investigational Site
      • Coimbra, Portugal
        • 1241.20.35104 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1241.20.35101 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 1241.20.35102 Boehringer Ingelheim Investigational Site
      • Vila Real, Portugal
        • 1241.20.35105 Boehringer Ingelheim Investigational Site
  • Romania
      • Bucharest, Romania
        • 1241.20.40001 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1241.20.40002 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1241.20.40003 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • 1241.20.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1241.20.70001 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1241.20.70004 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1241.20.70005 Boehringer Ingelheim Investigational Site
  • Spain
      • A Coruña, Spain
        • 1241.20.34007 Boehringer Ingelheim Investigational Site
      • Alicante, Spain
        • 1241.20.34004 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1241.20.34002 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1241.20.34005 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1241.20.34003 Boehringer Ingelheim Investigational Site
      • Majadahonda, Madrid, Spain
        • 1241.20.34001 Boehringer Ingelheim Investigational Site
      • Santander, Spain
        • 1241.20.34008 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1241.20.34006 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bristol, United Kingdom
        • 1241.20.44005 Boehringer Ingelheim Investigational Site
      • Liverpool, United Kingdom
        • 1241.20.44007 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1241.20.44001 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1241.20.44002 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1241.20.44006 Boehringer Ingelheim Investigational Site
      • Nottingham, United Kingdom
        • 1241.20.44004 Boehringer Ingelheim Investigational Site
      • Southampton, United Kingdom
        • 1241.20.44003 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Dothan, Alabama, United States
        • 1241.20.00026 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, United States
        • 1241.20.00033 Boehringer Ingelheim Investigational Site
      • La Mesa, California, United States
        • 1241.20.00006 Boehringer Ingelheim Investigational Site
      • Oceanside, California, United States
        • 1241.20.00003 Boehringer Ingelheim Investigational Site
      • Poway, California, United States
        • 1241.20.00008 Boehringer Ingelheim Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • 1241.20.00015 Boehringer Ingelheim Investigational Site
      • Fort Pierce, Florida, United States
        • 1241.20.00014 Boehringer Ingelheim Investigational Site
      • Maitland, Florida, United States
        • 1241.20.00004 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, United States
        • 1241.20.00010 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • 1241.20.00001 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1241.20.00018 Boehringer Ingelheim Investigational Site
      • Chevy Chase, Maryland, United States
        • 1241.20.00002 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States
        • 1241.20.00032 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1241.20.00009 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1241.20.00016 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1241.20.00031 Boehringer Ingelheim Investigational Site
      • Rochester, New York, United States
        • 1241.20.00019 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 1241.20.00024 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 1241.20.00013 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 1241.20.00005 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1241.20.00017 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1241.20.00012 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1241.20.00022 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 1241.20.00020 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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:

    1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
    2. liver biopsy typical of chronic hepatitis C , or
    3. history of elevated ALT at least 6 months prior to screening.
  • HCV infection of sub-GT1b confirmed by genotypic testing at screening

  • Treatment naïve defined as:

    1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
    2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection
  • Plasma HCV RNA > or = 1,000 IU/mL at screening
  • Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.
  • Age 18 to 75 years

  • Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization

    1. with documented hysterectomy, or
    2. who have had both ovaries removed, or
    3. with documented tubal ligation, or
    4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
    5. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms.

OR:

Male patients

  1. who are documented to be sterile, or
  2. who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and
  3. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).

Exclusion criteria:

  • HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  • HCV subtype 1a, mixed 1a/1b or GT1 undefined
  • Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
  • HIV-1 or HIV-2 infection
  • Hepatitis B virus (HBV) infection based on presence of HBs-Ag
  • Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,
  • International Normalized Ratio (INR) > or =1.7
  • Serum albumin < 3.3 g/dL
  • Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease
  • Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  • Patients with ongoing or historical photosensitivity or recurrent rash

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Allocated 24 weeks BI 207127 + BI 201335
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Drug: Ribavirin (RBV)
24 weeks of active RBV
Drug: BI 201335 (Faldaprevir)
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
Drug: BI 207127
24 weeks of BI 207127
Drug: BI 201335 (Faldaprevir)
24 weeks of BI 201335
Drug: Ribavirin (RBV)
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
Drug: BI 207127
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
EXPERIMENTAL: Randomized 16 weeks BI 7127+BI1335 + RBV
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Drug: Ribavirin (RBV)
24 weeks of active RBV
Drug: BI 201335 (Faldaprevir)
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
Drug: BI 207127
24 weeks of BI 207127
Drug: BI 201335 (Faldaprevir)
24 weeks of BI 201335
Drug: Ribavirin (RBV)
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
Drug: BI 207127
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
EXPERIMENTAL: Randomized 24weeks BI 7127+ BI1335 + RBV
24 weeks of BI 207127and BI 201335 in combination with RBV
Drug: Ribavirin (RBV)
24 weeks of active RBV
Drug: BI 207127
24 weeks of BI 207127
Drug: Ribavirin (RBV)
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
Drug: BI 207127
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
Drug: Faldaprevir (BI 201335)
24 weeks of 201335

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR12 Rates With Historical Control
Time Frame: 12 Week (post-treatment)
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
12 Week (post-treatment)
Comparisons of SVR12 Rates Across Treatment Arms
Time Frame: 12 Week (post-treatment)
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
12 Week (post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR4
Time Frame: 4 Week (post-treatment)
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
4 Week (post-treatment)
SVR24
Time Frame: 24 Week (post-treatment)
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
24 Week (post-treatment)

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.

General Publications

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

December 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (ESTIMATE)

November 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1241.20
  • 2012-003533-41 (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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