A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhigang Ren
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- AZVUDINE
- TAF
- IFNα-2a
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Zhigang Ren
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
Source ClinicalTrials.gov