Antiviral Therapy for Patients With Chronic Hepatitis B Infection

May 15, 2022 updated by: Lin Bingliang, Sun Yat-sen University

Exploratory Study on Antiviral Therapy for Patients With Chronic Hepatitis B Virus Infection (Immune Tolerance Period)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

238

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Bingliang Lin, Doctor
          • Phone Number: 86-20-85253165
          • Email: lamikin@126.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The inhibition rate of HBV-DNA between two groups
Time Frame: 96 weeks
compare the inhibition rate of HBV-DNA between two groups at 96 weeks
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The decrease of HBV DNA in the at 48 weeks between the two groups
Time Frame: 48 weeks
comparing the decrease of HBV DNA in the at 48 weeks between the two groups
48 weeks
The HBeAg seroconversion rates at 48 weeks and 96 weeks
Time Frame: 48 weeks and 96 weeks
comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups
48 weeks and 96 weeks
The changes of HBsAg
Time Frame: 48 weeks and 96 weeks
The changes of HBsAg at 48 weeks and 96 weeks were compared between the two groups
48 weeks and 96 weeks
adverse side effects
Time Frame: 4、12、24、48、72 and 96 weeks
comparing adverse side effects between the two groups
4、12、24、48、72 and 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 15, 2022

First Submitted That Met QC Criteria

May 15, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 15, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment for CHB infection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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