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Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991531
Collaborator
(none)
100
Enrollment
1
Location
24.5
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues
    Anticipated Study Start Date :
    Aug 15, 2023
    Anticipated Primary Completion Date :
    Aug 15, 2024
    Anticipated Study Completion Date :
    Aug 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The decrease of HBV RNA from baseline to 48 weeks [2023.8-2025.8]

      The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;

    Secondary Outcome Measures

    1. HBV RNA undetectable rate at 48 weeks; [2023.8-2025.8]

      After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks;

    2. The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels; [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;

    3. The association of HBV RNA changes with the liver stiffness; [2023.8-2025.8]

      During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness;

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 1.18 years old or above and the gender is not limited;

      1. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
      1. Patients with HBV DNA negative (HBV DNA<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
      1. Good compliance and voluntary signing of informed consent.
    Exclusion Criteria:
      1. Patients with decompensated cirrhosis;
      1. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
      1. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
      1. Patients have active or suspected malignancy or history of malignancy;
      1. Patients who were identified not appropriate for the study by investigators.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050

    Sponsors and Collaborators

    • Beijing Friendship Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT05991531
    Other Study ID Numbers:
    • Serum HBV RNA
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Aug 16, 2023