Antiviral Therapy for Patients With Chronic Hepatitis B Infection

Phase 2

Recruiting

• Conditions: Chronic Hepatitis B Virus Infection
• Interventions: Drug: Entecavir combined with Tenofovir Amibufenamide; Drug: Entecavir

• Registration Number: NCT05382351
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-10
• Study First Submitted: 2022-05-15
• Study First Submitted QC: 2022-05-15
• Last Update Submitted: 2022-05-15
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 238

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir and Tenofovir Amibufenamide group	Entecavir combined with Tenofovir Amibufenamide	Patients will receive the treatment of entecavir combined with tenofovir amibufenamide
Entecavir group	Entecavir	Patients receive treatment with entecavir

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
adverse side effects	4、12、24、48、72 and 96 weeks	comparing adverse side effects between the two groups
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 changes of HBsAg	48 weeks and 96 weeks	The changes of HBsAg at 48 weeks and 96 weeks were compared between the two groups

Trial Locations

Locations (1)

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