Four weeks treatment for chronic hepatitis C in patients under 50 years of age with no significant liver fibrosis - 4 RIBC

Department of infectious Diseases, Odense University Hospital0 个研究点目标入组 227 人开始时间: 2018年1月12日最近更新: 2021年10月18日

试验速览

暂无简介。

•Chronic hepatitis C defined as two positive HCV tests >6 month apart. First test can be anti-HCV, second test must be HCV-RNA
•Age 18-49
•Liver biopsy with F0 or F1 (Metavir score) with in a year of screening. If no liverbiopsy available, a Fibroscan <8 kPa at screening
•All HCV genotypes accepted
•Compliant as judged by study team
•Naïve to all hepatitis C treatment
•Negative pregnancy test for fertile women.
•Negative test for anti-HIV and HbsAg
•IV drug use within the last year including heroin assisted treatment or substitution treatment for opioid dependence
•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 227
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Risk of noncompliance
•Clinical signs of cirrhosis (liver biopsy not required), or cirrhosis suspected by blood tests. (INR >1,3 or platelets <130*109/L)
•Contraindication to treatment with study drugs
•oBreastfeeding
•oRefusal to use contraceptives
•oAllergy to study drug or components.
•Hemoglobin <7.0 mmol/l
•Severe cardiac or pulmonary disease where anemia could be a significant problem
•Receiving medication that have important interactions with study drugs
•Significant liver disease
•Renal impairment (eGFR<60ml/min)
•Unable to understand Danish
•Co-infection with Hepatitis B or HIV
•Any other significant clinical illness deemed to interfere with response to treatment.

发起方

Department of infectious Diseases, Odense University Hospital