A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01330316
First received: April 5, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Sustained Virological Response (SVR): Plasma HCV RNA level < 25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: 60 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: 72 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 normalisation: Alanine Aminotransferase in normal range 24 weeks after end of the originally planned treatment duration. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events (overall and by DAIDS grade) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of Adverse Events leading to treatment discontinuation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Occurrence of drug-related AEs as assessed by the Investigator [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Occurrence of laboratory test abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in laboratory test values over time [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Aspartate Aminotransferase normalisation: Aspartate Aminotransferase in normal range 24 weeks after end of the originally planned treatment duration. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: July 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 201335 for 24 weeks
BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Drug: BI 201335
BI 201335 for 24 weeks
Drug: PegIFN/RBV
PegIFN/RBV for 48 weeks

  Eligibility

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

Inclusion criteria:

Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.

  1. Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]).
  2. Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
  3. Female patients:

    • with documented hysterectomy,
    • who have had both ovaries removed,
    • with documented tubal ligation,
    • who are post-menopausal with last menstrual period at least 12 months prior to screening, or
    • 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 RBV 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 RBV.

    Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.

    or

    Male patients:

    • who are documented to be sterile, or
    • who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (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. 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 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).
  4. Signed informed consent form prior to trial participation.

Exclusion criteria:

  1. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.
  2. HIV co-infection
  3. Hepatitis B virus (HBV) infection based on presence of HBs-Ag
  4. 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)
  5. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
  6. 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
  7. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
  8. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. 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.
  9. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial.
  10. Known hypersensitivity to any ingredient of the study drugs.
  11. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330316

  Hide Study Locations
Locations
United States, Alabama
1220.48.0004 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arkansas
1220.48.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas, United States
United States, California
1220.48.0011 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1220.48.0018 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
United States, Florida
1220.48.0078 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1220.48.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida, United States
United States, Georgia
1220.48.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
United States, Illinois
1220.48.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Louisiana
1220.48.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
United States, Massachusetts
1220.48.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts, United States
1220.48.0065 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Mississippi
1220.48.0023 Boehringer Ingelheim Investigational Site
Tupelo, Mississippi, United States
United States, New Jersey
1220.48.0066 Boehringer Ingelheim Investigational Site
Neptune, New Jersey, United States
United States, New York
1220.48.0012 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, Oregon
1220.48.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Texas
1220.48.0063 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1220.48.0029 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1220.48.0017 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1220.48.0071 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1220.48.0081 Boehringer Ingelheim Investigational Site
Forth Worth, Texas, United States
Austria
1220.48.4302 Boehringer Ingelheim Investigational Site
Wien, Austria
1220.48.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1220.48.3201 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1220.48.3204 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1220.48.3203 Boehringer Ingelheim Investigational Site
Liège, Belgium
Canada, Alberta
1220.48.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1220.48.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.48.1016 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.48.1007 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, Manitoba
1220.48.1009 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, Ontario
1220.48.1005 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1220.48.1006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
France
1220.48.3301 Boehringer Ingelheim Investigational Site
Clichy Cedex, France
1220.48.3311 Boehringer Ingelheim Investigational Site
Lille Cedex, France
1220.48.3303 Boehringer Ingelheim Investigational Site
Marseille Cedex 08, France
1220.48.3304 Boehringer Ingelheim Investigational Site
Montpellier Cedex 5, France
1220.48.3305 Boehringer Ingelheim Investigational Site
Nice Cedex 3, France
1220.48.3316 Boehringer Ingelheim Investigational Site
Pessac Cedex, France
1220.48.3312 Boehringer Ingelheim Investigational Site
Saint Laurent du Var, France
Germany
1220.48.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
1220.48.4904 Boehringer Ingelheim Investigational Site
Berlin, Germany
1220.48.4913 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1220.48.4906 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1220.48.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1220.48.4908 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1220.48.4914 Boehringer Ingelheim Investigational Site
Kiel, Germany
1220.48.4911 Boehringer Ingelheim Investigational Site
Mainz, Germany
1220.48.4905 Boehringer Ingelheim Investigational Site
München, Germany
Japan
1220.48.8106 Boehringer Ingelheim Investigational Site
Chiba, Chiba, Japan
1220.48.8117 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa, Japan
1220.48.8116 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1220.48.8118 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
1220.48.8113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1220.48.8114 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1220.48.8119 Boehringer Ingelheim Investigational Site
Omura, Nagasaki, Japan
1220.48.8121 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
Korea, Republic of
1220.48.8205 Boehringer Ingelheim Investigational Site
Pusan, Korea, Republic of
1220.48.8204 Boehringer Ingelheim Investigational Site
Pusan, Korea, Republic of
1220.48.8207 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.48.8206 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.48.8201 Boehringer Ingelheim Investigational Site
Yangsan, Korea, Republic of
Portugal
1220.48.3503 Boehringer Ingelheim Investigational Site
Aveiro, Portugal
1220.48.3509 Boehringer Ingelheim Investigational Site
Barreiro, Portugal
1220.48.3501 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1220.48.3502 Boehringer Ingelheim Investigational Site
Porto, Portugal
Romania
1220.48.4002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
Russian Federation
1220.48.7001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1220.48.7004 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
Spain
1220.48.3406 Boehringer Ingelheim Investigational Site
A Coruña, Spain
1220.48.3402 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.48.3411 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.48.3404 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.48.3412 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.48.3405 Boehringer Ingelheim Investigational Site
Madrid, Spain
1220.48.3409 Boehringer Ingelheim Investigational Site
Madrid, Spain
1220.48.3410 Boehringer Ingelheim Investigational Site
Majadahonda-Madrid, Spain
1220.48.3403 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1220.48.3401 Boehringer Ingelheim Investigational Site
Valencia, Spain
Switzerland
1220.48.4106 Boehringer Ingelheim Investigational Site
Bern, Switzerland
Taiwan
1220.48.8802 China Medical University Hospital
Taichung, Taiwan
United Kingdom
1220.48.4405 Boehringer Ingelheim Investigational Site
Bristol, United Kingdom
1220.48.4409 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.48.4401 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1220.48.4408 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
1220.48.4407 Boehringer Ingelheim Investigational Site
Oxford, United Kingdom
1220.48.4403 Boehringer Ingelheim Investigational Site
Southampton, United Kingdom
1220.48.4404 Boehringer Ingelheim Investigational Site
Tooting, 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: NCT01330316     History of Changes
Other Study ID Numbers: 1220.48, 2011-000141-20
Study First Received: April 5, 2011
Last Updated: July 23, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Agence Nationale sécurité médicament et des produits santé
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
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
United Kingdom: Research Ethics Committee
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

ClinicalTrials.gov processed this record on October 19, 2014