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

NCT ID: NCT07307586

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B Azvudine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TAF Group

CHB patients with TAF treatment

Group Type ACTIVE_COMPARATOR

TAF

Intervention Type DRUG

CHB patients with TAF treatment

Azvudine Group

CHB patients with Azvudine treatment

Group Type EXPERIMENTAL

AZVUDINE

Intervention Type DRUG

CHB patients with Azvudine treatment

IFN α-2a Group

CHB patients with IFN α-2a treatment

Group Type ACTIVE_COMPARATOR

IFNα-2a

Intervention Type DRUG

CHB patients with IFNα-2a treatment

Interventions

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AZVUDINE

CHB patients with Azvudine treatment

Intervention Type DRUG

TAF

CHB patients with TAF treatment

Intervention Type DRUG

IFNα-2a

CHB patients with IFNα-2a treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhigang Ren

OTHER

Sponsor Role lead

Responsible Party

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Zhigang Ren

The First Affiliated Hospital of Zhengzhou University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhigang Ren, Dr.

Role: CONTACT

Phone: +8618703636245

Email: [email protected]

Facility Contacts

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Zhigang Ren, Dr.

Role: primary

Other Identifiers

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2025-KY-0607-002

Identifier Type: -

Identifier Source: org_study_id