New combo therapy aims to keep hepatitis b in check
NCT ID NCT07588009
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
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.
-
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.
- Massive Real-World database aims to map how chronic diseases interact
- Can a Two-Drug combo wipe out hepatitis b for good?
- Can a new pill push hepatitis b virus to undetectable levels?
- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?