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Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

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ClinicalTrials.gov Identifier: NCT05991531
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 16, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing Friendship Hospital

Study Description
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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
Chronic Hepatitis B Patients

Study Design
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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 15, 2023
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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;


Secondary Outcome Measures :
  1. 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;

  2. 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;

  3. 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;


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05991531


Contacts
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Contact: Hong Ma, Profession 010-63138747 mahongmd@aliyun.com
Contact: Jialing Zhou, Associate research fellow zhoujialing11@126.com

Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Contact: Hong Ma, Professor       mahongmd@aliyun.com   
Contact: Jialing Zhou, Associate research fellow       zhoujialing11@126.com   
Sponsors and Collaborators
Beijing Friendship Hospital
More Information
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Responsible Party: Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT05991531    
Other Study ID Numbers: Serum HBV RNA
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 16, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Chronic Disease
Disease Attributes
Pathologic Processes