orwegian Nucleoside Analogue Stop Study (Nuc-STOP) - A randomized open-label trial in HBeAg negative chronic hepatitis B, aiming at achieving a functional Cure

Oslo University Hospital HF0 个研究点目标入组 130 人开始时间: 2019年6月4日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Adults (18-70 years) with HBeAg negative chronic hepatitis B
•- HBeAg negative at start of antiviral therapy
•- Treated minimum 2 years with either tenofovir or entecavir without interruption
•- Full viral suppression >2 years: at least 3 measurements at least 6 months apart with at least 24 months between the first and last measurement.
•- Most recent liver fibrosis assessment, performed within the past 12 months, does not show advanced fibrosis (i.e. Metavir score
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- A history of decompensated liver disease, either by clinical signs (ascites, encephalopathy, portal hypertension, jaundice) or suggestive laboratory results (total bilirubin >38 umol/L, INR >1.5, platelets <75,000/mm3, serum albumin <30 g/L).
•- Any previous diagnosis of cirrhosis, either by liver biopsy (Metavir score F4) or elastography (Fibroscan >12 kPa). Elastography readings with concomitant ALT >200 U/L are not considered.
•- Previous HCC
•- Co-infections with HIV, hepatitis C or hepatitis D
•- Other disease or medication that can interfere with the study (e.g. ongoing alcohol or illicit drug abuse, immunosuppressive medication, other active liver disease, or any other condition which in the opinion of the physician is incompatible with participation)

发起方

Oslo University Hospital HF