A phase III, randomised, double-blind and placebo controlled study of once daily BI 201335, 240 mg for 12 or 24 weeks in combination with pegylated interferon-a and ribavirin in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN/RBV treatment - BI 201335 in TE patients

SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 625 人开始时间: 2011年4月22日最近更新: 2017年8月21日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
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

•1.1.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 randomization visit,
•Subject’s documentation of the liver biopsy or fibroscan performed will be requested at the randomization 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. female partners of childbearing potential shouldperform monthhly pregnancy tests from the date of screening until 7 months afer the last dose of RBV.
•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

排除标准

•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, incidental steaotosis disgnosis by biopsy is not an exclusion criteria
•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 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 within 28 days prior to randomization and throughout the treatment phase of this trial,
•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 laboratory values which add to >= 7 points (CPB) according to the Child-Turcotte-Pugh (CTP) classification,
•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, homicidal ideation, bipolar disorders, mania,
•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 autoimmune hepatitis,
•19.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 art

研究者

发起方

SCS Boehringer Ingelheim Comm.V

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