Azvudine tablets to promote clinical cure in people with chronic hepatitis B.

A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.

This trial tests whether azvudine tablets can help achieve clinical cure in adults with chronic hepatitis B who are HBeAg-positive, have high viral load and elevated ALT, and have not received prior antiviral treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07307586 on ClinicalTrials.gov

What this trial studies

This prospective Phase 3 study at The First Affiliated Hospital of Zhengzhou University enrolls a small sample of treatment‑naïve adults with HBeAg-positive chronic hepatitis B and follows them with regular viral load, liver function, and immune cell monitoring. Interventions listed include azvudine, tenofovir alafenamide (TAF), and interferon alfa-2a, reflecting an antiviral-plus-immune-activation strategy. Investigators will track HBV DNA, HBsAg levels, ALT, and immune markers over time to see if the regimen produces sustained HBsAg loss or clinical cure. Key eligibility criteria include HBeAg and HBsAg positivity for ≥6 months, HBV DNA >20,000 copies/mL, HBsAg <1,500 IU/mL, ALT >2×ULN, and no prior antiviral therapy, with exclusions for coinfections, cirrhosis, and autoimmune or metabolic liver disease.

Who should consider this trial

Good fit: Ideal candidates are treatment‑naïve adults with chronic hepatitis B who are HBeAg-positive, have HBV DNA >20,000 copies/mL, HBsAg <1,500 IU/mL, and ALT more than twice the upper limit of normal.

Not a fit: Patients with cirrhosis, coinfection with other hepatotropic viruses or HIV, significant metabolic or autoimmune liver disease, or prior antiviral therapy are excluded and would not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, the regimen could help some patients achieve HBsAg loss (clinical cure), lower HBV DNA, and reduce liver inflammation.

How similar studies have performed: Nucleos(t)ide analogues and interferon have reliably suppressed HBV DNA and sometimes induced HBeAg seroconversion in prior studies, but sustained HBsAg loss is uncommon, so combining antiviral and immune activation remains partly novel.

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 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.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Zhigang Ren, Dr.

Conditions Chronic Hepatitis B; Azvudine