Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA. (ALTHBV)

February 28, 2024 updated by: Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial

This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Qiumin Luo, Doctor
  • Phone Number: +8613632399075
  • Email: lqiumin@126.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University
        • 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

Description

Inclusion Criteria:

  • Positive hepatitis b surface antigen and hepatitis b antibody > 0.5 year;
  • Age from 18 to 65 years old;
  • Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
  • Positive Hepatitis b virus(HBV);
  • Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year.

Exclusion Criteria:

  • Other active liver diseases;
  • Hepatocellular carcinoma or other malignancy;
  • Pregnancy or lactation;
  • Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAF group
100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss.
Drug: Tenofovir alafenamide Fumarate
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Other Names:
  • Vemlidy
No Intervention: Observation group
100 patients would not receive treatment from baseline to life-long.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatitis b s antigen decrease from baseline
Time Frame: 48 week, 96 week, 144 week
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
48 week, 96 week, 144 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatitis b e antigen loss rate
Time Frame: 48 week, 96 week, 144 week
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
48 week, 96 week, 144 week
hepatitis b virus(HBV) DNA undetectable rate
Time Frame: 48 week, 96 week, 144 week
Hepatitis b virus DNA would not be detected if it below the upper limit of test value
48 week, 96 week, 144 week
hepatitis b virus(HBV) RNA undetectable rate
Time Frame: 48 week, 96 week, 144 week
Hepatitis b virus RNA would not be detected if it below the upper limit of test value
48 week, 96 week, 144 week
hepatitis b s antigen loss rate
Time Frame: 48 week, 96 week, 144 week
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
48 week, 96 week, 144 week

Collaborators and Investigators

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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Liang Peng, Doctor, Third Affiliated Hospital, 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)

June 4, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following the article publication.

IPD Sharing Access Criteria

Proposals should be directed to xxx@yyy. To gain access, data requestors need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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