New pill could help hepatitis b patients who Don't respond to standard care

NCT ID NCT07090759

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding GST-HG141 (Neracorvir) to standard antiviral therapy can better suppress the hepatitis B virus in patients who haven't responded adequately to current drugs. About 526 adults with chronic hepatitis B will receive either the experimental drug or a placebo, alongside their usual medication. The main goal is to see if the virus levels become undetectable during treatment.

What this could mean

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

Active substance
GST-HG141 (Neracorvir) – an experimental drug taken as a pill
What this could lead to
If successful, this could offer a new combination treatment option for people with chronic hepatitis B who don't respond well enough to current antiviral drugs.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

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 526 people

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

Started

Jul 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 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: 1. Male or female individuals aged 18-70 years (inclusive of the boundaries); 2. Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within the range of 18-35 kg/m2 (inclusive of the boundaries); 3. Have been continuously taking nucleoside analogues (entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], emivirofavir \[TMF\], or propivirofavir \[TAF\]) for more than one year (with a break of less than one month in the past year), and are receiving treatment at the time of screening and agree to accept the treatment plan provided by this study during the study period; \* Have maintained the same NA monotherapy for more than 3 months before screening 4. HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \> 50 IU/mL; 5. At the time of screening, ALT ≤ 5×ULN; 6. Male participants with a fertile female partner or female participants of childbearing age who are willing to voluntarily take effective contraceptive measures from the time of screening until 28 days after the completion of the study ; 7. Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol. Exclusion Criteria: 1. History of life-threatening severe allergic reactions such as anaphylactic shock, or allergy to the active ingredients or excipients of the study drug as suspected by the investigator; 2. Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening; 3. Systemic use of immunosuppressants, immunomodulators (interferon must be discontinued for more than 12 months), or cytotoxic drugs within 6 months prior to screening; or vaccination with live attenuated vaccines within 1 month prior to screening; 4. Presence of acute infections requiring treatment prior to randomization; 5. Clinically significant acute or chronic liver disease not caused by HBV infection, rendering the subject unsuitable for participating in the study as determined by the investigator; 6. Subjects with a history of cirrhosis (e.g., subjects who have undergone pathological examination of liver tissue with a report indicating cirrhosis or those who have undergone endoscopy indicating esophageal or gastric varices); or subjects with currently diagnosed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal or gastric varices, splenomegaly, and ascites; or subjects with significant progression of liver fibrosis; 7. Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 μg/L (or 20 ng/mL) or DCP\>40 mAU/mL or imaging suggesting possible malignant lesions in the liver; concurrent other malignancies or history of other malignancies within the past 5 years (except for cured basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ); 8. Presence of gastrointestinal impairment or gastrointestinal disease that may affect the absorption of oral medication in the judgment of the investigator, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, Grade \> 2 gastrointestinal symptoms at screening (e.g., nausea, vomiting, or diarrhea), etc.; 9. Concurrent severe diseases of the circulatory, respiratory, urinary, hematologic, metabolic, immune, psychiatric, neurological, renal, or other systems, rendering the subject unsuitable for participating in the study as determined by the investigator. 10. Subjects with major trauma or major surgery within 3 months prior to screening; or those who plan to undergo surgery during the study period; 11. Laboratory tests: 1. Platelet count \< 100 × 109/L; 2. White blood cell count \< 3.0 × 109/L; 3. Absolute neutrophil count \< 1.3 × 109/L; 4. Serum total bilirubin \> 2× ULN; 5. Albumin \< 35 g/L; 6. GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula); 7. International normalized ratio (INR) of prothrombin time \>1.5; 12. Positive for hepatitis C antibody, positive for HIV antigen/antibody, or positive for syphilis antibody with a positive RPR or TRUST test result; 13. History of sustained alcohol abuse within the past 3 years (weekly alcohol intake \> 14 units, where 1 unit of alcohol equals 1 bottle of 350 mL beer, 120 mL wine, or 30 mL of spirits at 40% alcohol content); 14. History of drug dependence or substance abuse; 15. Participation in clinical trials involving other investigational drugs or medical devices and receiving the investigational drug or using the medical device within 3 months prior to screening; 16. Women who are breastfeeding or tested positive for pregnancy; 17. Determined by the investigator to be unsuitable for this trial for any other reasons.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Shulan(Hangzhou) Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310011, China

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