Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

August 15, 2023 updated by: Beijing Friendship Hospital

Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues

Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years and with HBV DNA negative or LLV.

Description

Inclusion Criteria:

  • 1.18 years old or above and the gender is not limited;
  • 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
  • 3. Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
  • 4. Good compliance and voluntary signing of informed consent.

Exclusion Criteria:

  • 1. Patients with decompensated cirrhosis;
  • 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
  • 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
  • 4. Patients have active or suspected malignancy or history of malignancy;
  • 5. Patients who were identified not appropriate for the study by investigators.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The decrease of HBV RNA from baseline to 48 weeks
Time Frame: 2023.8-2025.8
The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;
2023.8-2025.8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV RNA undetectable rate at 48 weeks;
Time Frame: 2023.8-2025.8
After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks;
2023.8-2025.8
The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
Time Frame: 2023.8-2025.8
During 48 weeks of treatment, the investigators detect the association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
2023.8-2025.8
The association of HBV RNA changes with the liver stiffness;
Time Frame: 2023.8-2025.8
During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness;
2023.8-2025.8

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

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 (Estimated)

August 15, 2023

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 6, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serum HBV RNA

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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