Chronic Hepatitis B, Azvudine
Conditions
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.
Interventions
Sponsors
Zhigang Ren
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 or breastfeeding women, or those planning pregnancy within one year; 4. Patients who have received or are currently undergoing antineoplastic therapy; 5. History of alcohol or substance abuse; 6. Patients currently taking therapeutic medications or health supplements; 7. Patients who participated in other clinical trials within 30 days prior to enrolment; 8. Patients with allergic constitutions or hypersensitivity to any drug or component used in this study; 9. Patients with gastrointestinal disorders that may impair drug absorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up at 12 months | 12 month | Taking the medication orally for 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 30 days (form the date of confirmed CHB) | Discontinuation of medication due to adverse events or other reasons |
Countries
China
Contacts
Primary ContactZhigang Ren, Dr.
Outcome results
None listed