Home › Trials › NCT05937178

Observing antiviral treatment strategies for chronic hepatitis B in real-world settings

A Real-world Study of Optimizing Nucleotide-analogues-based Treatment for Chronic Hepatitis B

Observational Huashan Hospital · NCT05937178

This study looks at how well different antiviral treatments for chronic hepatitis B work in everyday medical settings for adults aged 18 to 80.

Quick facts

Study typeObservational
Enrollment20000 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorHuashan Hospital Academic / other
Locations44 sites (Hefei, Anhui and 43 other locations)
Trial IDNCT05937178 on ClinicalTrials.gov

What this trial studies

This multicenter, observational study aims to evaluate various antiviral treatment strategies for patients with chronic hepatitis B (CHB) in routine clinical settings across China. It will compare the effectiveness of first-line nucleos(t)ide analogues based on updated Chinese guidelines from 2022 against previous guidelines and foreign recommendations. The study will enroll treatment-naïve and treatment-experienced patients aged 18 to 80, collecting clinical data without additional interventions. Participants will be grouped based on their treatment initiation criteria and responses to previous treatments.

Who should consider this trial

Good fit: Ideal candidates include treatment-naïve or treatment-experienced patients aged 18-80 with chronic hepatitis B who meet specific criteria outlined in the study.

Not a fit: Patients with hepatitis B who do not meet the eligibility criteria or those who have contraindications for the antiviral treatments being observed may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could optimize antiviral treatment strategies for chronic hepatitis B, potentially improving patient outcomes.

How similar studies have performed: While this study explores a real-world approach to treatment, similar studies have shown varying degrees of success in optimizing antiviral therapies for chronic hepatitis B.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months.
* Age between 18-80 years.
* Patient who reads and signs informed consent.
* Meet any conditions of the group listed below

Group A-naïve and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline (observe-plan to treat or control-plan to follow-up) :

A. HBV DNA positive, ALT is continuously upper limit of normal (male 30 U/L, female 19 U/L) B. HBeAg positive, HBV DNA≤2×10\^7 IU/ml; HBeAg negative, HBV DNA≥2×10\^3 IU/ml C. Meet any of the conditions listed below

1. Age\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis;
2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis;
3. TE indicates significant fibrosis, and ≤30 years, without family history of cirrhosis or HCC

Group B-naïve and meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese Guidelines, but not in EASL or AASLD guideline (observe-plan to treat or control-plan to follow-up) :

A. Without cirrhosis, HBV DNA≤2000 IU/ml, ALT\>1 ULN； B. Without cirrhosis, HBV DNA\>2000 IU/ml, 1 ULN\<ALT≤2 ULN； C. Without cirrhosis, normal ALT, \>30 years, have a family history of cirrhosis or HCC, or TE indicates significant fibrosis; D. Without cirrhosis, HBV DNA 20-2000 IU/ml Group C-experienced and partial response (1. switch another first-line NA; 2. add-on another first-line NA; 3. switch another first-line NA and add-on peginterferon alpha; 4. continue the original plan) Treatment experienced patient who has received a first-line nucleos(t)ide analogue(NA) monotherapy for at least 48 weeks, i.e., entecavir, tenofovir disoproxil or tenofovir alafenamide, tenofovir amibufenamide, and has partial response. They plan to continue or change the therapy

Exclusion Criteria:

* Have poor compliance;
* Received contraindicated concomitant drugs (subjects receiving prohibited drugs will need at least 30 days of washing out period) and known hypersensitivity reactions to the study drug, metabolites, or formulated excipients;
* Any other clinical symptoms or previous treatment that the investigator considers that the individual subject is not suitable for this study or cannot comply with the administration requirements

Where this trial is running

Hefei, Anhui and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatitis B, Chronic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.