Comparisons of efficacy and safety between Tenofovir and Entecavir in chronic hepatitis B patients: an open level randomized clinical trial

Kaohsiung Chang Gung Memorial Hospital0 个研究点目标入组 288 人开始时间: 2019年9月3日最近更新: 2019年10月7日

适应症

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•The inclusion criteria included three populations:
•1. Chronic hepatitis B patients with hepatitis B virus surface antigen (HBsAg)
•1.1 Positive status for more than 6 months
•1.2 Elevated alanine transferase (ALT) levels = 5x ULN (200 IU/L) or ALT levels between 2x and 5x ULN combined HBV DNA =20000 IU/ml for HBeAg positive patients
•1.2 ALT levels over 2x ULN combined HBV DNA =2000 IU/ml for HBeAg negative patients
•2. Acute hepatic decompensated patient (prolong prothrombin time >3 sec and bilirubin>2 mg/dL) with positive for HBsAg
•3. Clinical cirrhosis with HBV DNA =2000 IU/ml. The clinical evidence of cirrhosis was defined by one of the following
•3.1 Ultrasound diagnosed liver cirrhosis with evidence of splenomegaly or esophageal or cardiac varices
•3.2 Liver biopsy diagnosed liver cirrhosis
•4. Aged 20 years or older.

•1. Patients who had co-infection with human immunodeficiency virus, hepatitis C virus, hepatitis D virus or hepatitis E virus by serological assays
•2. Patients who had a significant intake of alcohol (>20g/day for women; 30 g/day for men)

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