Chronic Hepatitis b
Conditions
Keywords
chronic hepatitis b, nucleoside, nucleotide
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.
Interventions
DRUGEntecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
DRUGTenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
DRUGTenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed