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New pill aims to control hepatitis b and boost immune response

NCT ID NCT07307586

Disease control Sponsor: Zhigang Ren Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests azvudine tablets in 120 people with chronic hepatitis B. The drug works by both fighting the virus and activating the immune system. Researchers will monitor viral load, liver function, and immune activity over 12 months to see if azvudine can help achieve clinical cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Azvudine tablets
What this could lead to
If successful, this could offer a new treatment option that controls hepatitis B virus and may lead to a clinical cure for some patients.
What could go wrong
This is a small early-phase study with only 120 participants, so results may not apply to everyone. The treatment may cause side effects or fail to control the virus long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Azvudine Chronic hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

More trials for these conditions

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