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

Not Applicable

Recruiting

• Conditions: Chronic Hepatitis b
• Interventions: Drug: Entecavir; Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir Alafenamide

• Registration Number: NCT04195074
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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

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 Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Last Update Submitted: 2019-12-15
• Last Update Posted: 2019-12-17
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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. HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
4. ALT≥2×ULN；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETV group	Entecavir	100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
TDF group	Tenofovir Disoproxil Fumarate	100 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
TAF group	Tenofovir Alafenamide	100 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.

Primary Outcome Measures

Name	Time	Method
Rate of hypercalcemia	144 week	The serum calcium would be detected to know the ratio of patients with hypercalcemia.
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.

Secondary Outcome Measures

Name	Time	Method
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
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 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.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China