A multi-centre single-arm study to evaluate the efficacy and safety of BOCEPREVIR 44 weeks in addition to standard of care (SOC) in previously treatment failure (relapser, non-responders, both partial and null) patients with chronic hepatitis C genotype 1 (G1) and cirrhosis (F4 Metavir)

MSD ITALIA S.R.L.0 个研究点目标入组 58 人开始时间: 2012年10月19日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1.Each subject must be willing and able to provide written informed consent for the trial 2.Each subject must be aged between 18 and 75 years included 3.Each subject must weigh between 40 kg and 125 Kg 4.Each subject must have documented CHC genotype 1 infection. 5.Each subject must have underwent a previous course of treatment with standard of care (SOC: Peg-interferon alpha 2a or Peg-interferon alpha 2b + Ribavirin) with a documented non response. 6.Each subject must have a certified diagnosis of cirrhosis 7.Each subject must have an ultrasound within 6 months of the Screening Visit with no findings suspicious for hepatocellular carcinoma (HCC). 8.Each subject and each subject’s partner(s), childbearing potential, must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug (7 months for male subject).
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1.The subject has co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive) 2.The subject has used any investigational drugs within 30 days of the randomization visit in this study 3.The subject is participating in any other clinical trial within 30 days of randomization or has intention to participate in another clinical trial during participation in this study. 4.The subject has evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. 5.The subject has clinically significant ocular examination findings 6.The subject has pre-existing significant psychiatric condition(s). 7.The subject has evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years. Subjects under evaluation for malignancy are not eligible. 8.The subject has the following laboratory values: -Hb <12 g/dL for females and <13 g/dL for males -Neutrophils <1500/ mm3 (blacks: <1200/mm3) -Platelets <70,000/ mm3 -Direct bilirubin >1.5 x upper limit of normal (ULN).-Serum albumin < lower limit of normal (LLN) 9.Serum creatinine >ULN 10.Prothrombin time (PT) values >10% above laboratory reference range.

发起方

MSD ITALIA S.R.L.