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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhigang Ren, Dr.
• Email: fccrenzg@zzu.edu.cn
• Phone: +8618703636245

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of functional cure on patient-reported outcomes in chronic hepatitis B

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• Sequential combination therapy for functional cure of chronic hepatitis B

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  Recruiting Phase 2 The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07852091

• Combination therapy for functional cure in chronic hepatitis B

  This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.

  Recruiting Phase 2 The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07845058

• GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B

  A phase IIa trial tests GST-HG131 and GST-HG141 tablets against placebo to see if they are safe and help people with chronic hepatitis B.

  Recruiting Phase 2 Fujian Akeylink Biotechnology Co., Ltd. · Beijing · NCT07709520

• AHB-137 injection in people with chronic hepatitis B

  This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.

  Recruiting at 34 sites Phase 2 Ausper Biopharma Co., Ltd. · Beijing, Beijing Municipality and 33 other locations · NCT07635186

• AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.