Chronic Hepatitis B Virus Infection
Conditions
Brief summary
The study aims to demonstrate that antiviral therapy for patients with immune tolerance of CHB. On the basis of the original antiviral therapy of entecavir, further clarify the safety and effectiveness of entecavir combined with tenofovir amibufenamide.The investigators plan to enroll about 328 hepatitis B patients,. who are in the stage of immune tolerance. These participants will be devided into two groups randomly .Group A will receive the treatment of entecavir. Group B will be treated with entecavir and tenofovir amibufenamide. The participants in both groups will be followed up for 96 weeks. The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4) Comparing adverse side effects between the two groups.
Detailed description
High HBV DNA level is an independent risk factor for liver cirrhosis and liver cancer, we know all patients with chronic hepatitis B virus infection in immune tolerance period had high viral load. So it is necessary to implement antiviral therapy for patients with chronic hepatitis B virus infection in immune tolerance period.Previous studies have found that combination of two antiviral drugs has a higher virological inhibition rate in patients with high viral load than single drug. Hence, the investigators' hypothesis is that treatment of patients with chronic hepatitis B virus infection in immune tolerance period result in higher virological inhibition rate and reduce of the risk of cirrhosis and liver cancer. The investigators plan to enroll about 328 hepatitis B patients, who are in the stage of immune tolerance. These participants will be devided into 2 groups.Group A will receive the treatment of entecavir . Group B will be treated with entecavir and tenofovir amibufenamide. The participants in both groups will be followed up for 96 weeks. Unless there are serious adverse drug reactions, the protocol cannot be adjusted within 96 weeks. The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4) Comparing adverse side effects between the two groups.
Interventions
DRUGEntecavir
Entecavir group will receive entecavir orally once a day, 0.5mg each time, and fasting for 2h before and after taking the medicine
DRUGEntecavir combined with Tenofovir Amibufenamide
Entecavir combined with Tenofovir Amibufenamide group will be treated with entecavir and tenofovir amibufenamide. Entecavir is administered in the same way as before. enofovir amibufenamide orally 25mg once a day with meals
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18-65 years old; 2. HBsAg positive \>6 months, HBsAg\>1\*10e4IU/ml; 3. HBV-DNA\> 2 \* 10e7IU / ml; 4. HBeAg positive; 5. ALT / AST remained normal which were followed up twice within 1 year with at least a 6-month interval each time. 6. No antiviral treatment with interferon or nucleoside (acid) analogues in the previous year
Exclusion criteria
1. infection with hepatitis A, C, D, E viruses or HIV infection ; 2. Combined with diabetes, hypertension, renal insufficiency, autoimmune diseases and other organ dysfunction And malignant tumors; 3. Patients using Immunosuppressive therapy or radiotherapy / chemotherapy for other diseases; 4. Patients with liver fibrosis, cirrhosis (FibroScan \> = 9.4kpa) and liver cancer were identified; 5. Extrahepatic manifestations related to HBV (glomerulonephritis, vasculitis, nodular polyarteritis, peripheral neuropathy, etc.); 6. Allergic to nucleoside drugs 7. Pregnancy or having pregnancy plan within 2 years and Lactating patients; 8. Patients who are unable to comply with the arrange ment of this study or sign the informed consent. 9. Failed to return to hospital regularly for follow-up ac- cording to the study plan. 10. Researchers determine other condition that does not fit into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The inhibition rate of HBV-DNA between two groups | 96 weeks | compare the inhibition rate of HBV-DNA between two groups at 96 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The decrease of HBV DNA in the at 48 weeks between the two groups | 48 weeks | comparing the decrease of HBV DNA in the at 48 weeks between the two groups |
| The HBeAg seroconversion rates at 48 weeks and 96 weeks | 48 weeks and 96 weeks | comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups |
| The changes of HBsAg | 48 weeks and 96 weeks | The changes of HBsAg at 48 weeks and 96 weeks were compared between the two groups |
| adverse side effects | 4、12、24、48、72 and 96 weeks | comparing adverse side effects between the two groups |
Countries
China
Outcome results
None listed