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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• the Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting
• Huashan Hospital
  Shanghai, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• Beijing YouAn Hospita
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Principal investigator: Wenghong Zhang, MD — Huashan Hospital
• Study coordinator: Wenghong Zhang, MD
• Email: zhangwenhong@fudan.edu.cn
• Phone: 13801844344

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AHB-137 for chronic hepatitis B in adults on nucleotide analogue therapy

  AHB-137 is being tested to see if it is safe and effective for adults with chronic hepatitis B who are currently on nucleos(t)ide analogue therapy.

  Recruiting Phase 2 AusperBio Therapeutics Inc. · Redwood City, California and 9 other locations · NCT07654283

• Oral and gum health and saliva markers in people with hepatitis B and D

  This project will test whether gum inflammation and specific saliva and gum-fluid markers differ in adults with hepatitis B and D—both those taking bulevirtide and those not—compared with healthy adults.

  Recruiting at 2 sites Research Center of Periodontal-Systemic Interactions · Craiova and 1 other locations · NCT07491848

• Entecavir Resistance Mutations in chronic hepatitis B patients in Turkey

  This study tests whether entecavir resistance mutations can be detected in adults with chronic hepatitis B, and whether prior lamivudine exposure increases the chance of those mutations appearing.

  Recruiting at 2 sites Guven Health Group · Adana and 9 other locations · NCT07459426

• AHB-137 for HBeAg-negative chronic hepatitis B in the Asia–Pacific

  This trial tests whether AHB-137 injections can improve outcomes for adults in the Asia–Pacific with HBeAg-negative chronic hepatitis B who are already on nucleos(t)ide therapy.

  Recruiting at 9 sites Phase 2 AusperBio Therapeutics Inc. · Fitzroy, Victoria and 9 other locations · NCT07370207

• Sequential PEG-IFN for Hepatitis B After RNA-targeted Therapy

  This study tests whether starting or delaying a 24-week course of pegylated interferon helps people with chronic hepatitis B who previously used ASO/siRNA therapies.

  Recruiting at 2 sites Huashan Hospital · Beijing, China and 1 other locations · NCT06923280

• Evaluating a new gene therapy for chronic hepatitis B

  This study is testing a new gene therapy for adults with chronic hepatitis B to see if it is safe and effective in fighting the virus.

  Recruiting at 7 sites Phase 1 Precision BioSciences, Inc. · Boston, Massachusetts and 6 other locations · NCT06680232

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.