Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ETV,TDF,TAF,TMF, Peginterferon α-2b injection.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis b. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study is a multicenter, prospective, observational real-world study designed to investigate and analyze the current treatment patterns of chronic hepatitis B (CHB) across 200 hospitals in China. By comparing patient outcomes under different therapeutic regimens, it aims to provide high-quality evidence-based medical data to optimize CHB treatment strategies and follow-up protocols, ultimately contributing to the advancement of a functional cure for chronic hepatitis B.
Interventions
- Drug ETV,TDF,TAF,TMF
treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF) - Drug Peginterferon α-2b injection
treated with Peginterferon α-2b injection
Primary outcome measures
- Percentage of patients with HBsAg-associated HCC post-therapy [Time frame: Week 4-240]
- Hepatocellular Carcinoma (HCC) Incidence [Time frame: Week 4-240]
Secondary outcome measures (12)
- Number of chronic hepatitis B (CHB) patients with accurate knowledge/awareness of HBV [Time frame: Week 4-240]
- Rate of HBsAg seroclearance [Time frame: Week 4-240]
- HBsAg seroconversion rate [Time frame: Week 4-240]
- Number of patients with altered HBsAg levels post-treatment [Time frame: Week 4-240]
- Number of patients with HBsAg level decline from baseline [Time frame: Week 4-240]
- HBeAg seroconversion rate [Time frame: Week 4-240]
- HBV DNA [Time frame: Week 4-240]
- Liver fibrosis improvement rate [Time frame: Week 4-240]
- Incidence of liver cirrhosis [Time frame: Week 4-240]
- Incidence of decompensated cirrhosis [Time frame: Week 4-240]
- Incidence of decompensation-related complications [Time frame: Week 4-240]
- Liver transplantation incidence rate [Time frame: Week 4-240]
Eligibility criteria
Inclusion criteria
- 1.Chronic HBV infection (HBsAg-positive for ≥6 months); 2.Age ≥18 years; 3.Patients who, based on real-world clinical practice needs, are planned or currently receiving treatment with:Entecavir (ETV),Tenofovir disoproxil fumarate (TDF),Tenofovir alafenamide fumarate (TAF),Tenofovir amibufenamide (TMF) OR Pegylated interferon α-2b-naïve patients OR Patients re-initiating pegylated interferon α-2b therapy; 4.Written informed consent obtained from the patient.
Exclusion criteria
- 1.Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 162 centers
- Huaxian People's Hospital — Anyang
- Linzhou City People's Hospital — Anyang
- Neihuang County People's Hospital — Anyang
- Tangyin County People's Hospital — Anyang
- The Fifth People's Hospital of Anyang — Anyang
- The First Affiliated Hospital of Xinxiang Medical University (Hua County Branch) — Anyang
- Guangzhou First People's Hospital — Guangzhou
- The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital) — Guangzhou
- … and 154 more centers
Identifiers
NCT: NCT07169656 · 2024-KY-0976-001