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

NCT07307586 | Recruiting Phase 3 DMC

• 1 other identifier: 2025-KY-0607-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B; Azvudine

Outcome Measures

Primary Outcomes (1)

• Follow-up at 12 months

  Taking the medication orally for 12 months.

  12 month

Secondary Outcomes (1)

• Adverse events

  Up to 30 days (form the date of confirmed CHB)

Study Arms (3)

TAF Group

ACTIVE COMPARATOR

CHB patients with TAF treatment

Drug: TAF

Azvudine Group

EXPERIMENTAL

CHB patients with Azvudine treatment

Drug: AZVUDINE

IFN α-2a Group

ACTIVE COMPARATOR

CHB patients with IFN α-2a treatment

Drug: IFNα-2a

Interventions

IFNα-2a DRUG

CHB patients with IFNα-2a treatment

IFN α-2a Group

AZVUDINE DRUG

CHB patients with Azvudine treatment

Azvudine Group

TAF DRUG

CHB patients with TAF treatment

TAF Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• HBV DNA load \> 20,000 copies/mL and HBsAg \< 1,500 IU/mL;
• Serum alanine aminotransferase (ALT) \> 2 times the upper limit of normal;
• No prior antiviral therapy prior to hospital admission.

You may not qualify if:

• All subjects meeting any of the following criteria shall be excluded from this study:
• Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV;
• Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions;
• Pregnant or breastfeeding women, or those planning pregnancy within one year;
• Patients who have received or are currently undergoing antineoplastic therapy;
• History of alcohol or substance abuse;
• Patients currently taking therapeutic medications or health supplements;
• Patients who participated in other clinical trials within 30 days prior to enrolment;
• Patients with allergic constitutions or hypersensitivity to any drug or component used in this study;
• Patients with gastrointestinal disorders that may impair drug absorption.

Sponsors & Collaborators

• Zhigang Ren: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

azvudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhigang Ren, Dr.

CONTACT

+8618703636245; fccrenzg@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-11

Locations

CN (1)