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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01343888
First received: April 20, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.


Condition Intervention Phase
Hepatitis C
Drug: PegIFN/RBV
Drug: BI 201335
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma HCV RNA level < 25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response after 24 weeks of treatment discontinuation (SVR24): - Plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Early Treatment Success (ETS): - Plasma HCV RNA level < 25 IU/mL (detected or undetected) at Week 4 and HCV RNA < 25 IU/mL, undetected at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Alanine Aminotransferase and Aspartate Aminotransferase normalisation: Alanine Aminotransferase and Aspartate Aminotransferase in normal range at end of treatment and post-treatment [ Time Frame: 48 & 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 656
Study Start Date: April 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PegIFN/RBV
PegIFN/RBV for 48 weeks
Drug: PegIFN/RBV
PegIFN/RBV for 48 weeks
Experimental: BI 201335 for 12 or 24 weeks
BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Drug: BI 201335
BI 201335 once daily low dose
Experimental: BI 201335 for 12 weeks
BI 201335 once daily high dose for 12 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Drug: BI 201335
BI 201335 once daily high dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:

    1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
    2. liver biopsy consistent with chronic HCV infection.
  2. HCV genotype 1 infection confirmed by genotypic testing at screening.
  3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
  4. HCV RNA = 1,000 IU/mL at screening
  5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.

    Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomization need not be repeated. Biopsies may be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy in patients at risk for the procedure should not exclude such patients from a trial.

  6. Age 18 to 70 years
  7. Female patients:

    1. with documented hysterectomy,
    2. who have had both ovaries removed,
    3. with documented tubal ligation,
    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 Day 1, that, if sexually active, 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 in addition to the consistent and correct use of a condom. Patients must agree not to 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 ethinyl estradiol containing contraceptives, diaphragm with spermicide substance and intra-uterine device.

    Male patients:

    1. who are documented to be sterile, or
    2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential should 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).
  8. Signed informed consent form prior to trial participation

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion.
  3. HIV co-infection
  4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag
  5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
  7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
  8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
  9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomization. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
  10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomization and throughout the treatment phase of this trial.
  11. Known hypersensitivity to any ingredient of the study drugs.
  12. Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).

Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343888

  Hide Study Locations
Locations
Austria
1220.30.4303 Boehringer Ingelheim Investigational Site
Linz, Austria
1220.30.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
1220.30.4302 Boehringer Ingelheim Investigational Site
Wien, Austria
1220.30.4304 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1220.30.3201 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1220.30.3207 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1220.30.3204 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1220.30.3205 Boehringer Ingelheim Investigational Site
Gent, Belgium
1220.30.3202 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1220.30.3203 Boehringer Ingelheim Investigational Site
Liège, Belgium
France
1220.30.3314 Boehringer Ingelheim Investigational Site
Clermont-Ferrand, France
1220.30.3301 Boehringer Ingelheim Investigational Site
Clichy, France
1220.30.3311 Boehringer Ingelheim Investigational Site
Lille, France
1220.30.3303 Boehringer Ingelheim Investigational Site
Marseille, France
1220.30.3304 Boehringer Ingelheim Investigational Site
Montpellier, France
1220.30.3305 Boehringer Ingelheim Investigational Site
Nice Cedex 3, France
1220.30.3302 Boehringer Ingelheim Investigational Site
Paris, France
1220.30.3309 Boehringer Ingelheim Investigational Site
Paris Cedex 20, France
1220.30.3316 Boehringer Ingelheim Investigational Site
Pessac Cedex, France
1220.30.3315 Boehringer Ingelheim Investigational Site
Rennes Cedex 09, France
1220.30.3312 Boehringer Ingelheim Investigational Site
Saint Laurent du Var, France
1220.30.3313 Boehringer Ingelheim Investigational Site
Toulouse, France
Germany
1220.30.4917 Boehringer Ingelheim Investigational Site
Aachen, Germany
1220.30.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
1220.30.4904 Boehringer Ingelheim Investigational Site
Berlin, Germany
1220.30.4916 Boehringer Ingelheim Investigational Site
Bonn, Germany
1220.30.4913 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1220.30.4906 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1220.30.4909 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1220.30.4912 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1220.30.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1220.30.4908 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1220.30.4907 Boehringer Ingelheim Investigational Site
Herne, Germany
1220.30.4914 Boehringer Ingelheim Investigational Site
Kiel, Germany
1220.30.4903 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1220.30.4911 Boehringer Ingelheim Investigational Site
Mainz, Germany
1220.30.4905 Boehringer Ingelheim Investigational Site
München, Germany
1220.30.4915 Boehringer Ingelheim Investigational Site
Ulm, Germany
Japan
1220.30.8106 Boehringer Ingelheim Investigational Site
Chiba, Chiba, Japan
1220.30.8111 Boehringer Ingelheim Investigational Site
Gifu, Gifu, Japan
1220.30.8107 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo, Japan
1220.30.8112 Boehringer Ingelheim Investigational Site
Izunokuni, Shizuoka, Japan
1220.30.8108 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1220.30.8117 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa, Japan
1220.30.8109 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi, Japan
1220.30.8116 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1220.30.8118 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
1220.30.8110 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano, Japan
1220.30.8113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1220.30.8105 Boehringer Ingelheim Investigational Site
Namegata, Ibaraki, Japan
1220.30.8114 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1220.30.8119 Boehringer Ingelheim Investigational Site
Omura, Nagasaki, Japan
1220.30.8122 Boehringer Ingelheim Investigational Site
Omuta, Fukuoka, Japan
1220.30.8121 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1220.30.8101 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1220.30.8102 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1220.30.8115 Boehringer Ingelheim Investigational Site
Tanabe, Wakayama, Japan
1220.30.8104 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki, Japan
Portugal
1220.30.3503 Boehringer Ingelheim Investigational Site
Aveiro, Portugal
1220.30.3509 Boehringer Ingelheim Investigational Site
Barreiro, Portugal
1220.30.3506 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1220.30.3507 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1220.30.3505 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1220.30.3501 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1220.30.3502 Boehringer Ingelheim Investigational Site
Porto, Portugal
1220.30.3504 Boehringer Ingelheim Investigational Site
Vila Real, Portugal
Romania
1220.30.4001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1220.30.4002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1220.30.4003 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1220.30.4004 Boehringer Ingelheim Investigational Site
Bucharest, Romania
Russian Federation
1220.30.7002 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1220.30.7001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1220.30.7004 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1220.30.7005 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1220.30.7006 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1220.30.7007 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Spain
1220.30.3406 Boehringer Ingelheim Investigational Site
A Coruña, Spain
1220.30.3402 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.30.3404 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.30.3405 Boehringer Ingelheim Investigational Site
Madrid, Spain
1220.30.3408 Boehringer Ingelheim Investigational Site
Santander, Spain
1220.30.3403 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1220.30.3401 Boehringer Ingelheim Investigational Site
Valencia, Spain
1220.30.3407 Boehringer Ingelheim Investigational Site
Vigo (Pontevedra), Spain
Switzerland
1220.30.4106 Boehringer Ingelheim Investigational Site
Bern, Switzerland
1220.30.4103 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds, Switzerland
1220.30.4107 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1220.30.4108 Boehringer Ingelheim Investigational Site
St. Gallen, Switzerland
1220.30.4101 Boehringer Ingelheim Investigational Site
Zürich, Switzerland
United Kingdom
1220.30.4405 Boehringer Ingelheim Investigational Site
Bristol, United Kingdom
1220.30.4410 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.30.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.30.4409 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.30.4401 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1220.30.4408 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
1220.30.4407 Boehringer Ingelheim Investigational Site
Oxford, United Kingdom
1220.30.4403 Boehringer Ingelheim Investigational Site
Southampton, United Kingdom
1220.30.4406 Boehringer Ingelheim Investigational Site
Whitechapel, London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01343888     History of Changes
Other Study ID Numbers: 1220.30, 2010-021716-42
Study First Received: April 20, 2011
Last Updated: March 17, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014