Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

N/AUnknownNCT04196998

Third Affiliated Hospital, Sun Yat-Sen University150 enrolled

Overview

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Hepatitis b virus infection remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of hepatitis b virus related compensated cirrhosis. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Hepatitis B Compensated Cirrhosis

Interventions

EntecavirDRUG

Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.

Tenofovir Disoproxil FumarateDRUG

Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.

Tenofovir alafenamideDRUG

Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year; 2. Age from 18 to 65 years old; 3. Hepatitis b virus DNA positive; 4. Cirrhosis or portal hypertension is found through ultrasonography, computed tomography or magnetic resonance imaging; 5. Do not receive nucleotide/nucleoside analogues treatment in the past half year. Exclusion Criteria: 1. Complications of decompensated cirrhosis: ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc; 2. Other active liver diseases; 3. Hepatocellular carcinoma or other malignancy; 4. Pregnancy or lactation; 5. Human immunodeficiency virus infection or congenital immune deficiency diseases; 6. Severe diabetes, autoimmune diseases; 7. Other important organ dysfunctions; 8. Using glucocorticoid; 9. Patients can not follow-up; 10. Investigator considering inappropriate.

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of decompensated cirrhosis

Incidence of decompensated cirrhosis is evaluated in the follow-up

Time frame: 144 week

Secondary Outcomes

Ratio of patients with undetectable hepatitis b virus DNA after treatment

Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.