Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04195074

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Drug: Entecavir Drug: Tenofovir Disoproxil Fumarate Drug: Tenofovir Alafenamide	N/A

Detailed Description

Chronic hepatitis b (CHB) 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 CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ETV group 100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.	Drug: Entecavir Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day. Other Names: Baraclude
Experimental: TDF group 100 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.	Drug: Tenofovir Disoproxil Fumarate Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day. Other Names: Viread
Experimental: TAF group 100 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.	Drug: Tenofovir Alafenamide Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day. Other Names: Vemlidy

Arm

Intervention/Treatment

Experimental: ETV group

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

Drug: Entecavir

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

Other Names:

Baraclude

Experimental: TDF group

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

Drug: Tenofovir Disoproxil Fumarate

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

Other Names:

Viread

Experimental: TAF group

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

Drug: Tenofovir Alafenamide

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

Other Names:

Vemlidy

Outcome Measures

Primary Outcome Measures

Rate of renal function decline [144 week]
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
Rate of hypercalcemia [144 week]
The serum calcium would be detected to know the ratio of patients with hypercalcemia.

Secondary Outcome Measures

hepatitis b virus(HBV) DNA undetectable rate [0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week]
Hepatitis b virus DNA would not be detected if it below the upper limit of test value.
hepatitis b e antigen loss rate [0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week]
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
hepatitis b s antigen loss rate [0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week]
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value.
hepatitis b e antigen seroconversion rate [0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week]
hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
Age from 18 to 65 years old;
HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
ALT≥2×ULN；
Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

Other active liver diseases;
Hepatocellular carcinoma or other malignancy;
Pregnancy or lactation;
Human immunodeficiency virus infection or congenital immune deficiency diseases;
Severe diabetes, autoimmune diseases;
Other important organ dysfunctions;
Using glucocorticoid;
Patients can not follow-up;
Investigator considering inappropriate.