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New combo therapy aims to keep hepatitis b in check

NCT ID NCT07588009

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new drug called GST-HG141 (Nairecovir) combined with standard antivirals in 576 adults with chronic hepatitis B. Participants have already completed 48 weeks of treatment in an earlier study. The goal is to see if the combination is safe and helps keep the virus under control over the long term.

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 (also called Nairecovir) combined with nucleoside analog antivirals
What this could lead to
If successful, this could provide a new combination therapy to better control chronic hepatitis B over the long term.
What could go wrong
This is an extension study focused on safety and tolerability, not a cure. It builds on earlier results, but long-term benefits and risks are still being evaluated.

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 576 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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 71 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. Participants who received the study treatment of the phase III clinical trial of GST-HG141 (GST-HG141-III-01) in accordance with the protocol requirements (participants without early withdrawal and with overall medication compliance ≥ 80%), and had ALT ≤ 5×ULN; 2. Participants were willing to participate in the study and were judged by the investigator to be suitable for long-term treatment with GST-HG141 combined with NAs; 3. Male participants with female partners of childbearing potential or female participants of childbearing potential voluntarily adopted effective contraceptive measures from screening to 28 days after study withdrawal ; 4. Signed the informed consent form prior to the trial and were able to complete the study in accordance with the requirements of the trial protocol. Exclusion Criteria: 1. Presence of severe systemic infection requiring treatment; 2. Suffering from clinically significant acute or chronic liver diseases not caused by HBV infection; 3. Participants with a history of liver cirrhosis; or currently diagnosed or suspected decompensated liver cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, splenomegaly, ascites, etc.; or participants with significant progression of liver fibrosis; 4. Primary liver cancer; suspected malignant space-occupying liver lesions suggested by imaging examination; combined with other malignant tumors (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix); 5. Impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator; 6. Combined with severe diseases of the circulatory, respiratory, urinary, hematological, metabolic, immune, psychiatric, neurological, renal and other systems, and judged by the investigator to be ineligible for continued participation in the study; 7. Participants with major trauma or major surgery within 3 months prior to screening; or those planning to undergo surgery during the study period; 8. Laboratory test abnormalities: 1. Platelet count \< 100×10\^9/L; 2. White blood cell count \< 3.0×10\^9/L; 3. Absolute neutrophil count \< 1.3×10\^9/L; 4. Serum total bilirubin \> 2×ULN; 5. Albumin \< 35 g/L; 6. Estimated glomerular filtration rate (eGFR) ≤ 60 ml·min-¹·(1.73m²)-¹ ; 7. International Normalized Ratio (INR) of prothrombin time \> 1.5; 9. Lactating females or participants with a positive pregnancy test; 10. Participants with any other conditions deemed inappropriate for participation in this trial by the investigator.

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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 official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.