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

ConditionsChronic Hepatitis BAzvudine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhigang Ren

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZVUDINE

    Drug

    CHB patients with Azvudine treatment

  • TAF

    Drug

    CHB patients with TAF treatment

  • IFNα-2a

    Drug

    CHB patients with IFNα-2a treatment

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: TAF GroupActive comparator 1 intervention
Group B: Azvudine GroupExperimental treatment 1 intervention
Group C: IFN α-2a GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Follow-up at 12 months

Taking the medication orally for 12 months.

Time frame
12 month

Secondary outcomes

1

Adverse events

Discontinuation of medication due to adverse events or other reasons

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhigang Ren

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov
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