A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
Recruiting · NCT07307586 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhigang Ren
View the official record on ClinicalTrials.gov →Interventions studied
AZVUDINEIFNα-2aTAF
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China