Chronic hepatitis C infection genotype 1 MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. Confirmed prior virological failure (non-response) or (relapse) with an approved dose of PegIFN/RBV defined as following : • Null response: Absence of HCV RNA drop by =2 log10 from baseline at Week 12, Lack of Early Virological Response (EVR), • Partial response: (Partial Responder and Breakthrough) HCV RNA drop by =2 log10 from baseline at Week 12 (EVR) but not achieving HCV RNA undetectable at end of treatment (based on an assay considered sensitive at the time of treatment), • Prior relapse: Undetectable HCV RNA (based on an assay considered sensitive at the time of treatment) at the end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow up. 4. HCV RNA =1,000 IU/mL at screening, 5. Documentation of liver biopsy within 3 years or fibroscan within 6 months prior to screening visit, Subject’s documentation of the liver biopsy or fibroscan performed will be requested at the screening visit, 6. Age 18 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 prior to trial participation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 565 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. HCV infection of mixed genotype diagnosed by genotypic testing at screening, 2- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection, 3- HIV co-infection, 4- 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 screening. 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 within 28 days prior to screening, 11- Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa 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, 14- Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding, and/or any laboratory results of any of the following: a International normalized ratio (INR) of =1.7, b Serum Albumin =3.5 g/dL, c Serum total bilirubin =2.0 mg/dL (except Gilbert’s syndrome), 15. 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, a period of disability or impairment due to a psychiatric disease within the past 5 years, 16. 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, 17. Clinical evidence of chronic pulmonary disease associated with functional impairment, 18. Active autoimmune disease, including autoi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this trial are: 1. Evaluate the efficacy and the safety of BI 201335, 240 mg given for 12 or 24 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed (previous partial responders or relapsers) a prior PegIFN/RBV treatment. 2. Evaluate the efficacy and the safety of BI 201335, 240 mg given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to historical PegIFN/RBV in chronic genotype 1 hepatitis C virus infected patients who failed (previous null-responders) a prior PegIFN/RBV treatment. ; Secondary Objective: To evaluate the safety and efficacy of two different treatment regimens with BI 201335 (240 mg given for 12 or 24 weeks) in combination with PegIFN/RBV (24 or 48 weeks). ;Primary end point(s): Sustained Virological Response (SVR): Plasma HCV RNA <25 IU/mL undetected at 24 weeks after the originally planned treatment duration.;Timepoint(s) of evaluation of this end point: 24 weeks after the originally planned treatment duration | — |
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 normalisation. ALT normal 24 weeks after end of the originally planned treatment duration. ; Timepoint(s) of evaluation of this end point: •12 weeks of treatment discontinuation •at Week 4 and week 8, •24 weeks after end of the originally planned treatment duration. | — |
Countries
Austria, Belgium, Canada, France, Germany, Japan, Portugal, Romania, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed