Chronic Hepatitis B
Conditions
Keywords
Hepatitis B
Brief summary
The goal of this prospective observational study is to determine the effects of concomitant administration of Bacteroides fragilis and Branched-Chain Amino Acids on hepatitis B virus clearance. The primary question it aims to answer is whether this concomitant administration can promote HBV clearance. The study will observe the HBV clearance rate in chronic hepatitis B patients who receive Bacteroides fragilis and BCAA as a supplement to their routine antiviral therapy. For comparison, researchers will compare the clearance rate in this group to that observed in a control group of chronic hepatitis B patients receiving a standard antiviral regimen based on PegIFNα2b and nucleoside analogs.
Interventions
DRUGPegIFNα2b+Nucleoside analog
The patients receive both PegIFNα2b and Nucleoside analog therapy.
DRUGPegIFNα2b+Nucleoside analog+Bacteroides fragilis+Branched-Chain Amino Acids
The patients received the concomitant administration of Bacteroides fragilis and BCAA, supplemented to their ongoing combination therapy with PegIFNα2b and Nucleoside analog.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- chronic hepatitis B patients
Exclusion criteria
* patients with malignancies * patients with other liver diseases * pregnancy patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg clearance | 48 months | HBsAg clearance is confirmed when two consecutive measurements, taken at an interval of at least 2 weeks, demonstrate HBsAg levels below the assay's lower limit of detection (\< 0.05 IU/mL) as quantitatively determined by the Abbott Architect-i2000SR system with Chemiluminescent Microparticle Immunoassay (CMIA) technology. |
Countries
China
Contacts
Primary ContactJinShui Pan
Outcome results
None listed