NCT07307586RecruitingPhase 3
A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Zhigang Ren
- Diseases
- Hepatitis B
- NCT number
- NCT07307586
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 1 Sept 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.