Chronic Hepatitis BPhase 3NCT07307586
A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
A Phase 3 study testing AZVUDINE, TAF and IFNα-2a in people with Chronic Hepatitis B and Azvudine, run by Zhigang Ren at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B, Azvudine
- What is being tested?
- AZVUDINE, TAF and IFNα-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must meet the following criteria to be eligible for inclusion in the trial:
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhigang Ren, Dr., +8618703636245, fccrenzg@zzu.edu.cn
About this study
Official title: A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.
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
- Being tested
- AZVUDINE, TAF, IFNα-2a
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZVUDINEDrug
CHB patients with Azvudine treatment
TAFDrug
CHB patients with TAF treatment
IFNα-2aDrug
CHB patients with IFNα-2a treatment
| Study group | Role | What they receive |
|---|---|---|
| TAF Group | Active comparator | CHB patients with TAF treatment Receives: Drug: TAF |
| Azvudine Group | Experimental | CHB patients with Azvudine treatment Receives: Drug: AZVUDINE |
| IFN α-2a Group | Active comparator | CHB patients with IFN α-2a treatment Receives: Drug: IFNα-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up at 12 months
Taking the medication orally for 12 months.
Measured: 12 month
Secondary outcomes (1)
Adverse events
Discontinuation of medication due to adverse events or other reasons
Measured: Up to 30 days (form the date of confirmed CHB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhigang Ren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhigang Ren, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307586
- Sponsor's protocol ID
- 2025-KY-0607-002
- Status last verified
- Nov 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.
- ClinicalTrials.gov ID
- NCT07307586
- Acronym / sponsor ID
- 2025-KY-0607-002
- Conditions
- Chronic Hepatitis B, Azvudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhigang RenUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAF Group | Active comparator | Drug: TAFCHB patients with TAF treatment |
| Azvudine Group | Experimental | Drug: AZVUDINECHB patients with Azvudine treatment |
| IFN α-2a Group | Active comparator | Drug: IFNα-2aCHB patients with IFN α-2a treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects must meet the following criteria to be eligible for inclusion in the trial:
Key exclusion criteria (10 listed)
- All subjects meeting any of the following criteria shall be excluded from this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZVUDINECHB patients with Azvudine treatment | Drug | Azvudine Group |
| TAFCHB patients with TAF treatment | Drug | TAF Group |
| IFNα-2aCHB patients with IFNα-2a treatment | Drug | IFN α-2a Group |
Primary outcome
Follow-up at 12 months
Time frame: 12 month
Taking the medication orally for 12 months.
1 secondary outcome
Adverse events
Time frame: Up to 30 days (form the date of confirmed CHB)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZVUDINE, TAF and IFNα-2a in people with Chronic Hepatitis B and Azvudine, run by Zhigang Ren at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Ren, Dr. (+8618703636245, fccrenzg@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up at 12 months (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.