A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
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: AZVUDINE, TAF, IFNα-2a.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis B, Azvudine. Basic parameters: 18 years — 65 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 →
Official title
A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.
Overview
Through regular monitoring of viral load, liver function and immune cell activity, the long-term efficacy of Adefovir in controlling HBV is precisely evaluated. By employing a dual mechanism of "antiviral action plus immune activation", it offers a novel therapeutic option for achieving clinical cure in chronic hepatitis B.
Interventions
- Drug AZVUDINE
CHB patients with Azvudine treatment - Drug TAF
CHB patients with TAF treatment - Drug IFNα-2a
CHB patients with IFNα-2a treatment
Primary outcome measures
- Follow-up at 12 months [Time frame: 12 month]
Secondary outcome measures (1)
- Adverse events [Time frame: Up to 30 days (form the date of confirmed CHB)]
Eligibility criteria
Inclusion criteria
- All subjects must meet the following criteria to be eligible for inclusion in the trial:
- Meet the diagnostic criteria for viral hepatitis as outlined in the Chinese Medical Association's Hepatology Branch Guidelines for the Prevention and Treatment of Chronic Hepatitis B, with patients demonstrating sustained positivity for hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) for at least six months;
- HBV DNA load > 20,000 copies/mL and HBsAg < 1,500 IU/mL;
- Serum alanine aminotransferase (ALT) > 2 times the upper limit of normal;
- No prior antiviral therapy prior to hospital admission.
Exclusion criteria
- All subjects meeting any of the following criteria shall be excluded from this study:
- Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV;
- Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions;
- Pregnant or breastfeeding women, or those planning pregnancy within one year;
- Patients who have received or are currently undergoing antineoplastic therapy;
- History of alcohol or substance abuse;
- Patients currently taking therapeutic medications or health supplements;
- Patients who participated in other clinical trials within 30 days prior to enrolment;
- Patients with allergic constitutions or hypersensitivity to any drug or component used in this study;
- Patients with gastrointestinal disorders that may impair drug absorption.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07307586 · 2025-KY-0607-002