Status:
UNKNOWN
Antiviral Therapy for Patients With Chronic Hepatitis B Infection
Lead Sponsor:
Sun Yat-sen University
Conditions:
Chronic Hepatitis B Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 effectivenes...
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 ...
Eligibility Criteria
Inclusion
- Age between 18-65 years old;
- HBsAg positive \>6 months, HBsAg\>1\*10e4IU/ml;
- HBV-DNA\> 2 \* 10e7IU / ml;
- HBeAg positive;
- ALT / AST remained normal which were followed up twice within 1 year with at least a 6-month interval each time.
- No antiviral treatment with interferon or nucleoside (acid) analogues in the previous year
Exclusion
- infection with hepatitis A, C, D, E viruses or HIV infection ;
- Combined with diabetes, hypertension, renal insufficiency, autoimmune diseases and other organ dysfunction And malignant tumors;
- Patients using Immunosuppressive therapy or radiotherapy / chemotherapy for other diseases;
- Patients with liver fibrosis, cirrhosis (FibroScan \> = 9.4kpa) and liver cancer were identified;
- Extrahepatic manifestations related to HBV (glomerulonephritis, vasculitis, nodular polyarteritis, peripheral neuropathy, etc.);
- Allergic to nucleoside drugs
- Pregnancy or having pregnancy plan within 2 years and Lactating patients;
- Patients who are unable to comply with the arrange ment of this study or sign the informed consent.
- Failed to return to hospital regularly for follow-up ac- cording to the study plan.
- Researchers determine other condition that does not fit into the study.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT05382351
Start Date
May 10 2022
End Date
December 31 2024
Last Update
May 19 2022
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630