Chronic Hepatitis B
Conditions
Interventions
A:Entecavir Monotherapy Group:None
B:Tenofovir Amibufenamide Monotherapy Group:None
C:Pradefovir Mesylate Tablets Monotherapy Group:None
D:TMF+ Peg-IFNa Combination Therapy :None
E:PDF+ Peg-IFNa Combination Therapy:None
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the Informed Consent Form (ICF), demonstrate understanding of the study, and be willing and able to comply with all trial procedures. 2.Aged 18–65 years (inclusive), any gender. 3.Treatment-naïve chronic hepatitis B (CHB) patients diagnosed according to the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B. 4.Have first- or second-degree relatives with HBV-related cirrhosis or hepatocellular carcinoma (HCC). (First-degree relatives: parents, children, full siblings; Second-degree relatives: uncles, aunts, grandparents) 5.Deemed by the investigator to be capable of adhering to the trial protocol and cooperating with data collection.
Exclusion criteria
Exclusion criteria: 1.Presence of clinically significant chronic diseases other than CHB that, in the investigator’s judgment, render the patient unsuitable for study participation. 2.Pre-existing cirrhosis, hepatocellular carcinoma (HCC), or prior hepatic failure before trial initiation. 3.Imaging findings indicative of cirrhosis, liver tumors, or nodules (with the exception of hepatic cysts or hemangiomas) prior to trial initiation. 4.History of confirmed comorbidities including hepatitis C (HCV), autoimmune hepatitis (AIH), alcoholic liver disease (ALD), drug-induced liver injury (DILI), or hereditary metabolic liver disorders (excluding non-alcoholic fatty liver disease [NAFLD]). 5.History or recurrence of malignancy within 5 years prior to the first dose of the investigational product (excluding thyroid carcinoma). 6.Prior organ transplantation. 7.Severe cardiac diseases (including myocardial infarction, unstable angina, heart failure [NYHA Class III or IV]), respiratory failure, renal failure, or pancreatitis. 8.Uncontrolled diabetes (glycated hemoglobin HbA1c =7.5%) despite medication. 9.Current or prior diagnosis of psychiatric disorders or major depressive disorder. 10.Participation in another clinical trial involving investigational drugs or biological agents within 30 days or 5 half-lives of the drug prior to the first dose of the investigational product. 11.Pregnant women or women planning pregnancy. 12.Any other condition deemed by the investigator to compromise patient suitability for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Incidence Rates of Cirrhosis, Hepatocellular Carcinoma (HCC), and Hepatic Failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg Seroconversion Rate;HBsAg Seroconversion Rate;Improvement in Liver Fibrosis; | — |
Countries
China
Contacts
Public ContactZhenhua Zhang
The Second Hospital of Anhui Medical University
Outcome results
None listed