A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B; Azvudine
• Intervention / Treatment: Drug: TAF; Drug: AZVUDINE; Drug: IFNα-2a

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhigang Ren, Dr.; Phone Number: +8618703636245; Email: fccrenzg@zzu.edu.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • the First Affiliated Hospital of Zhengzhou University
      • Contact: Zhigang Ren, Dr.; Phone Number: +8618703636245; Email: fccrenzg@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAF Group; CHB patients with TAF treatment	Drug: TAF; CHB patients with TAF treatment
Experimental: Azvudine Group; CHB patients with Azvudine treatment	Drug: AZVUDINE; CHB patients with Azvudine treatment
Active Comparator: IFN α-2a Group; CHB patients with IFN α-2a treatment	Drug: IFNα-2a; CHB patients with IFNα-2a treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up at 12 months	Taking the medication orally for 12 months.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Discontinuation of medication due to adverse events or other reasons	Up to 30 days (form the date of confirmed CHB)

Collaborators and Investigators

• Sponsor: Zhigang Ren

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic; azvudine
• Other Study ID Numbers: 2025-KY-0607-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No