Actively Recruiting
A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B
Led by Zhigang Ren · Updated on 2025-12-29
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term effects of Azvudine tablets in patients with chronic hepatitis B, a liver infection caused by the hepatitis B virus (HBV). This trial compares Azvudine with two other treatments, TAF and IFN alpha-2a, to evaluate their ability to control HBV through a combination of antiviral action and immune system activation. The study aims to find a new treatment option that may help achieve clinical cure in chronic hepatitis B patients aged 18 to 65 years. Participants are randomly assigned to one of three groups receiving either Azvudine, TAF, or IFN alpha-2a treatment. The study is conducted as a phase 3 clinical trial with a single masking approach to monitor effects without bias. Patients receive their assigned treatment and are followed closely to compare how well each therapy controls the virus and impacts immune activity. During the 12-month follow-up period, researchers will regularly monitor patients' viral load, liver function, and immune cell activity to assess treatment effectiveness. They will also track any adverse events for up to 30 days after confirmed chronic hepatitis B diagnosis. This detailed monitoring helps ensure participant safety and provides comprehensive data on the treatments' long-term impact.
CONDITIONS
Brief Title
A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for viral hepatitis with positive hepatitis B e antigen and surface antigen for at least 6 months
- HBV DNA load greater than 20,000 copies/mL and HBsAg less than 1,500 IU/mL
- Serum alanine aminotransferase (ALT) more than twice the upper limit of normal
- No prior antiviral therapy before hospital admission
- Age between 18 and 65 years
You will not qualify if you...
- Co-infection with other hepatotropic viruses such as hepatitis A, C, D, E, or HIV
- Presence of liver metabolic disorders, cirrhosis, autoimmune diseases, or other chronic conditions
- Pregnant or breastfeeding women, or planning pregnancy within one year
- Current or prior antineoplastic therapy
- History of alcohol or substance abuse
- Taking therapeutic medications or health supplements
- Participation in other clinical trials within 30 days before enrollment
- Allergic or hypersensitive to any drug or component used in the study
- Gastrointestinal disorders that may impair drug absorption
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive Azvudine, TAF, or IFN α-2a as treatment for chronic hepatitis B.
Regular visits during treatment period
Duration - Up to 30 days after treatment
Participants are monitored for safety and adverse events after treatment completion.
1 to 2 visits for safety assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Z
Zhigang Ren, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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