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

Sun Yat-sen University

Status: Unknown

Conditions: Compensated Cirrhosis; Hepatitis B

Treatments: Drug: Entecavir; Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir alafenamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04196998

XWX2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

ETV group

Active Comparator group

Description:

50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.

Treatment:

Drug: Entecavir

TDF group

Active Comparator group

Description:

50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.

Treatment:

Drug: Tenofovir Disoproxil Fumarate

TAF group

Experimental group

Description:

50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.

Treatment:

Drug: Tenofovir alafenamide