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Recruiting Phase 3 NCT07307586

A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B

Trial Parameters

Condition Chronic Hepatitis B
Sponsor Zhigang Ren
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-09-01
Completion 2026-12-31
Interventions
AZVUDINETAFIFNα-2a

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * All subjects must meet the following criteria to be eligible for inclusion in the trial: 1. 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; 2. HBV DNA load \> 20,000 copies/mL and HBsAg \< 1,500 IU/mL; 3. Serum alanine aminotransferase (ALT) \> 2 times the upper limit of normal; 4. No prior antiviral therapy prior to hospital admission. Exclusion Criteria: * All subjects meeting any of the following criteria shall be excluded from this study: 1. Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV; 2. Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions; 3. Pregnant o

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