Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-15

Study Completion Date

2025-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Hepatitis B Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No