genotype 1 chronic hepatitis C infection MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: BI 201335
Product Code: BI 201335
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BI 201335
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to: a. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or, b. 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 the screening visit. 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 should not exclude patients from a trial. 6. Age 18 to 70 years 7. Female patients: a. with documented hysterectomy, b. who have had both ovaries removed, c. with documented tubal ligation, d. who are post-menopausal with last menstrual period at least 12 months prior to screening, or e. 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: a. who are documented to be sterile, or b. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 randomization. Patients being treated with oral antivirals such as acyclovir, famiclovir 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). 13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory values which add up to = 7 points according to the Child-Turcotte-Pugh (CTP) classification (Appendix 10.6) 14. Pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, homicidal ideation, bipolar disorders, mania, a period of disability or impairment due to a psychiatric disease within the past 5 years. 15. Clinical evidence of significant or unstable cardiovascular disease, including angina, myocardial infarction within 6 months, pulmonary hypertension, cardiomyopathy, congestive heart failure, uncontrolled hypertension, significant arrhythmia or clinically significant abnormalities on ECG at screening. 16. Clinical evidence of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease) associated with functional impairment. 17. Active autoimmune disease, including autoimmune hepatitis. 18. History or evidence of retinopathy or clinically significant ophthalmological disorder including diabetic or hypertensive retinopathy, retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy, or retinal artery/vein obstruction. An eye examination performed within 6 months prior to randomization (Visit 2) is required. 19. Organ transplant h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to show superior efficacy of treatment with BI 201335 combined with PegIFN/RBV as compared to PegIFN/RBV alone (SOC).;Secondary Objective: To evaluate the safety and efficacy of two different treatment regimens with BI 201335 (240 mg given for 12 weeks or BI 201335 120 mg given for 12 or 24 weeks (BI-RGT) both in combination with PegIFN/RBV as compared to standard of care (SOC) with PegIFN/RBV alone ;Primary end point(s): Sustained Virological Response (SVR12): Plasma HCV RNA <25 IU/mL and undetected at 12 weeks after the originally planned treatment duration.;Timepoint(s) of evaluation of this end point: 72 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Virological response after 12 weeks of treatment discontinuation (SVR12): Plasma HCV RNA level < 25 IU/mL, undetected; 12 weeks after the originally planned treatment duration. 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. ALT and AST normalisation. ALT and AST normal at end of treatment and post-treatment ;Timepoint(s) of evaluation of this end point: 8 weeks / 24 weeks / 60 weeks | — |
Countries
Austria, Belgium, European Union, France, Germany, Japan, Portugal, Romania, Russian Federation, Spain, Switzerland, United Kingdom
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed