Compensated Cirrhosis, Hepatitis B
Conditions
Keywords
hepatitis b virus, compensated cirrhosis, nucleoside, nucleotide
Brief summary
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.
Detailed 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.
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of decompensated cirrhosis | 144 week | Incidence of decompensated cirrhosis is evaluated in the follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients with hepatitis b virus e antigen seroconversion after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Hepatitis b virus e antigen and e antibody would be tested to know the ratio of patients with hepatitis b virus e antigen seroconversion at 7 time points after treatment. |
| Ratio of patients with undetectable hepatitis b virus surface antigen after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Hepatitis b virus surface antigen would be tested to know the ratio of patients with undetectable hepatitis b virus surface antigen at 7 time points after treatment. |
| Serum calcium | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Hypocalcemia would be evaluated after treatment |
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | 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. |
| Blood urea nitrogen | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Blood urea nitrogen would be tested after treatment |
| Serum creatinine | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Serum creatinine would be tested after treatment |
| Estimated glomerular filtration rate | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Estimated glomerular filtration rate would be evaluated after treatment |
| Serum phosphorus | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | Hypophosphatemia would be evaluated after treatment |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed