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Antiviral Therapy for Patients With Chronic Hepatitis B Infection

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05382351
Collaborator
(none)
238
Enrollment
1
Location
2
Arms
31.7
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
238 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Exploratory Study on Antiviral Therapy for Patients With Chronic Hepatitis B Virus Infection (Immune Tolerance Period)
Actual Study Start Date :
May 10, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Entecavir group

Patients receive treatment with entecavir

Drug: Entecavir
Entecavir group will receive entecavir orally once a day, 0.5mg each time, and fasting for 2h before and after taking the medicine
Other Names:
  • Boludine/Rui fu en

    		•
    Experimental: Entecavir and Tenofovir Amibufenamide group

    Patients will receive the treatment of entecavir combined with tenofovir amibufenamide

    Drug: Entecavir 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
    Other Names:
  • Heng mu

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. adverse side effects [4、12、24、48、72 and 96 weeks]

      comparing adverse side effects between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510630

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lin Bingliang, Exploratory study on antiviral therapy for patients with chronic hepatitis B virus infection (immune tolerance period), Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05382351
    Other Study ID Numbers:
    • Treatment for CHB infection
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Virus Diseases
    Herpesviridae Infections
    Hepatitis
    Hepatitis, Chronic
    Tenofovir
    Entecavir

    Study Results

    No Results Posted as of May 19, 2022