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

Zhigang Ren

Status and phase: Enrolling; Phase 3

Conditions: Azvudine; Chronic Hepatitis B

Treatments: Drug: TAF; Drug: AZVUDINE; Drug: IFNα-2a

Study type: Interventional

Funder types: Other

Identifiers

NCT07307586

2025-KY-0607-002

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

TAF Group

Active Comparator group

Description:

CHB patients with TAF treatment

Treatment:

Drug: TAF

Azvudine Group

Experimental group

Description:

CHB patients with Azvudine treatment

Treatment:

Drug: AZVUDINE

IFN α-2a Group

Active Comparator group

Description:

CHB patients with IFN α-2a treatment

Treatment:

Drug: IFNα-2a