New drug combo aims to silence hepatitis b virus
NCT ID NCT07709520
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This phase II trial tests whether two experimental drugs, GST-HG131 and GST-HG141, can safely reduce hepatitis B surface antigen (HBsAg) levels in people with chronic hepatitis B. The study involves 80 adults aged 35-65. Participants receive either the drug combination or a placebo, and researchers measure HBsAg decline after 168 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- two experimental drugs called GST-HG131 and GST-HG141
- What this could lead to
- If successful, this combination could point toward a new way to control chronic hepatitis B and reduce the risk of liver damage.
- What could go wrong
- This is an early phase II trial with only 80 participants, so results may not apply broadly. The drugs may not lower HBsAg enough or could cause unexpected side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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35 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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. Able to sign the informed consent form and fully understand the test content, process and possible adverse reactions. 2. Males and females aged 35-65 years(inclusive),able to complete research in accordance with test plan requirements. 3. Participants who have no childbearing plan in a year,and must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 6 months after the last dose of the study. 4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive). 5. Participants who have received stable NA therapy for more than half a year, and have maintained the NA regimen for ≥3 months prior to Screening. 6. HBV DNA concentration must be adequately suppressed, defined as At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ . 7. HBeAg negative, 100≤HBsAg ≤1500 IU/mL, serum Alanine aminotransferase (ALT)\<1×upper limit of normal(ULN) during screening. 8. Able to communicate well with clinical staff and complete the trial according to protocol requirements. Exclusion Criteria: 1. Participants with a history of allergy to any component of the investigational product, or allergic diathesis (allergies to multiple drugs and foods). 2. Participants unable to tolerate venous blood collection, or with a history of needle syncope or blood phobia. 3. Participants who sustained major trauma or underwent major surgery within 3 months prior to screening, or those planning to undergo surgery during the study period. 4. Participants with a history of alcohol abuse (defined as alcohol intake \>14 standard units per week; one standard unit equals 350 mL beer, 120 mL wine, or 30 mL spirits with 40% alcohol by volume) or drug abuse/dependence at screening. 5. Participants who participated in a clinical trial of any medicinal product or medical device (excluding in vitro diagnostic reagents) and received the investigational product or device within 3 months prior to study drug administration. 6. Participants who received any anti-hepatitis B medications other than nucleos(t)ide analogues (NUCs), including marketed and unapproved agents, within 6 months prior to study drug administration. 7. Participants who received immunosuppressants, immunomodulators (thymosin, interferons) or cytotoxic drugs within 6 months before study drug administration; or patients who received live attenuated vaccines or live vaccines within 1 month prior to screening. 8. Participants with clinically significant acute or chronic liver disease unrelated to HBV infection (non-alcoholic fatty liver disease shall be assessed by the investigator for exclusion eligibility). 9. Participants with a medical history of liver cirrhosis or progressive liver fibrosis, defined as: liver histopathology confirming cirrhosis; endoscopy showing esophageal and gastric varices; or liver stiffness measurement (LSM) ≥9.0 kPa on transient elastography at screening. 10. Participants with confirmed or suspected decompensated HBV-related cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, variceal bleeding of esophagus and stomach, splenomegaly, ascites, and primary liver cancer. 11. Participants with concurrent malignant tumors or a history of other malignancies within 5 years prior to screening (excluding cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix); participants complicated with unstable cardiovascular and cerebrovascular diseases, uncontrolled diabetes (glycated hemoglobin \>7%), refractory hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, deemed ineligible by the investigator for study participation), or other relevant comorbidities. 12. Participants judged by the investigator to have gastrointestinal impairment or disorders that may interfere with oral drug absorption, including severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, or gastrointestinal symptoms graded \>Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) at screening (e.g., nausea, vomiting, diarrhea). 13. Participants with suspected or confirmed acute or chronic infection within 2 weeks prior to randomization. 14. Abnormal laboratory parameters meeting any of the following thresholds: Platelet count \<100×10⁹/L; White blood cell count \<3.0×10⁹/L; Absolute neutrophil count \<1.3×10⁹/L; Serum total bilirubin \>2× upper limit of normal (ULN); Serum albumin \<35 g/L; Creatinine clearance ≤60 mL/min (calculated via the CKD-EPI equation); International normalized ratio (INR) of prothrombin time \>1.5. 15. Participants with alpha-fetoprotein (AFP) \>50 µg/L or imaging suggestive of suspected malignant hepatic space-occupying lesions. 16. Participants positive for hepatitis C virus antibody (HCV-Ab); positive for Treponema pallidum antibody (TP-Ab) with positive rapid plasma reagin (RPR) test; or positive for human immunodeficiency virus antibody (HIV-Ab). 17. Female participants with positive serum pregnancy test at screening or baseline, or breastfeeding women. 18. Any other conditions deemed by the investigator to impair the participant's ability to provide informed consent or comply with the study protocol; participants judged unsuitable for trial participation; or circumstances where participation may compromise trial integrity or personal safety.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Friendship Hospital, Capital Medical University
RECRUITINGBeijing, China
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Other studies related to the condition(s) this trial covers.
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