Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01579474
First received: April 12, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients


Condition Intervention Phase
Hepatitis C
Drug: BI 201335 high dose
Drug: BI201335 low dose
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: Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • No (no primary efficacy endpoints is ste inthe trial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained virological response (SVR), defined as plasma HCV RNV undetectable at 24 week after end of treatment [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
  • SVR12, defined as plasma HCV RNA undetectable at 12 weeks after end of treatment [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]
  • Early treatment success (ETS), defined as plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA undetectable at Week 8 [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • ALT normalization, defined as ALT normal at 24 weeks after end of treatment [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. BI201335 low dose plus PegIFN/RBV
low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
Drug: BI201335 low dose
BI 201335 low dose with PegIFN/RBV
Experimental: 2. BI201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
Drug: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
Experimental: 3. BI201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
Drug: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
Experimental: 4. BI201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
Drug: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV

  Eligibility

Ages Eligible for Study:   20 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:

    • positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
    • liver biopsy consistent with chronic HCV infection.
  2. HCV genotype 1 infection confirmed by genotypic testing at screening
  3. (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
  4. HCV RNA = 100,000 IU/mL at screening
  5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
  6. Age 20 to 70 years
  7. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.

    or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.

  8. Signed informed consent form before 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. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.
  3. HIV co-infection,
  4. Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
  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 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 patient's 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 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,
  10. Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
  11. (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
  12. Known hypersensitivity to any ingredient of the study drugs,
  13. 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: NCT01579474

Locations
Japan
1220.54.08104 Boehringer Ingelheim Investigational Site
Chuo-ku, Chiba, Japan
1220.54.08118 Boehringer Ingelheim Investigational Site
Chuo-ku, Kobe, Hyogo, Japan
1220.54.08108 Boehringer Ingelheim Investigational Site
Fukui, Fukui, Japan
1220.54.08110 Boehringer Ingelheim Investigational Site
Gifu, Gifu, Japan
1220.54.08105 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo, Japan
1220.54.08112 Boehringer Ingelheim Investigational Site
Izunokuni, Shizuoka, Japan
1220.54.08107 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa, Japan
1220.54.08120 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa, Japan
1220.54.08109 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi, Japan
1220.54.08123 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
1220.54.08121 Boehringer Ingelheim Investigational Site
Mtsuyama, Ehime, Japan
1220.54.08113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1220.54.08117 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1220.54.08111 Boehringer Ingelheim Investigational Site
Ogaki, Gifu, Japan
1220.54.08124 Boehringer Ingelheim Investigational Site
Oo mura, Nagasaki,, Japan
1220.54.08115 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1220.54.08116 Boehringer Ingelheim Investigational Site
Osakasayama, Osaka, Japan
1220.54.08101 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1220.54.08102 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1220.54.08119 Boehringer Ingelheim Investigational Site
Tanabe, Wakayama, Japan
1220.54.08106 Boehringer Ingelheim Investigational Site
Toyama,Toyama, Japan
1220.54.08114 Boehringer Ingelheim Investigational Site
Tsu, Mie, Japan
1220.54.08122 Boehringer Ingelheim Investigational Site
Yahatanishi-ku, Kitakyusyu, Fukuoka, Japan
1220.54.08125 Boehringer Ingelheim Investigational Site
Yamagata, Yamagata, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01579474     History of Changes
Other Study ID Numbers: 1220.54
Study First Received: April 12, 2012
Last Updated: January 15, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014