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-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infection

Boehringer Ingelheim International GmbH0 个研究点目标入组 625 人开始时间: 2011年1月26日最近更新: 2015年1月26日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Boehringer Ingelheim International GmbH
入组人数: 625

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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

研究者

发起方

Boehringer Ingelheim International GmbH

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