NCT07307586 A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
| NCT ID | NCT07307586 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zhigang Ren |
| Condition | Chronic Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07307586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07307586 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT07307586 currently recruiting?
Yes, NCT07307586 is actively recruiting participants. Contact the research team at fccrenzg@zzu.edu.cn for enrollment information.
Where is the NCT07307586 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07307586 clinical trial?
NCT07307586 is sponsored by Zhigang Ren. The trial plans to enroll 120 participants.