Chronic Hepatitis BPhase 2NCT07709520
Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis B
A Phase 2 study testing GST-HG141 and GST-HG131 in people with Chronic Hepatitis B, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- GST-HG141 and GST-HG131
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to sign the informed consent form and fully understand the test content, process and possible adverse reactions.
- Males and females aged 35-65 years(inclusive),able to complete research in accordance with test plan requirements.
- 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.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive).
- 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.
- 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 .
- HBeAg negative, 100≤HBsAg ≤1500 IU/mL, serum Alanine aminotransferase (ALT)<1×upper limit of normal(ULN) during screening.
- Able to communicate well with clinical staff and complete the trial according to protocol requirements.
Who cannot join
- Participants with a history of allergy to any component of the investigational product, or allergic diathesis (allergies to multiple drugs and foods).
- Participants unable to tolerate venous blood collection, or with a history of needle syncope or blood phobia.
- 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.
- 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.
- 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.
- 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.
Show all 19Show fewer
- 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.
- 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).
- 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.
- 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.
- 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.
- 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).
- Participants with suspected or confirmed acute or chronic infection within 2 weeks prior to randomization.
- 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.
- Participants with alpha-fetoprotein (AFP) >50 µg/L or imaging suggestive of suspected malignant hepatic space-occupying lesions.
- 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).
- Female participants with positive serum pregnancy test at screening or baseline, or breastfeeding women.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Jia jidong, Dr., jia_jd@ccmu.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of GST-HG131/ GST-HG141 Tablets in Patients With Chronic Hepatitis B
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B
- Conditions
- Chronic Hepatitis B
- Being tested
- GST-HG141, GST-HG131, GST-HG141 Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG141Drug
GST-HG141 is a novel, potent and selective HBV CAM, which has a distinct molecular mechanism of its antiviral action compared to other CAMs reported in the literature, and has demonstrated strong antiviral properties in pre-clinical studies in vitro and in vivo.
GST-HG131Drug
GST-HG131 is a novel dihydroquinolizinone (DHQ) compound, has been shown to reduce circulating levels of HBsAg in animals.
GST-HG141 PlaceboDrug
GST-HG141 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | GST-HG141/GST-HG131 Receives: Drug: GST-HG141; Drug: GST-HG131 |
| Placebo 1 | Placebo comparator | GST-HG141 Placebo /GST-HG131 Receives: Drug: GST-HG131; Drug: GST-HG141 Placebo |
| Placebo 2 | Placebo comparator | GST-HG141 Placebo/GST-HG131 Receives: Drug: GST-HG131; Drug: GST-HG141 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg decline from baseline at D168
Measured: : Baseline and up to 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709520
- Sponsor's protocol ID
- GST-HG131&141-II-01
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of GST-HG131/ GST-HG141 Tablets in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07709520
- Acronym / sponsor ID
- GST-HG131&141-II-01
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: GST-HG141, Drug: GST-HG131GST-HG141/GST-HG131 |
| Placebo 1 | Placebo comparator | Drug: GST-HG131, Drug: GST-HG141 PlaceboGST-HG141 Placebo /GST-HG131 |
| Placebo 2 | Placebo comparator | Drug: GST-HG131, Drug: GST-HG141 PlaceboGST-HG141 Placebo/GST-HG131 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to sign the informed consent form and fully understand the test content, process and possible adverse reactions.
- Males and females aged 35-65 years(inclusive),able to complete research in accordance with test plan requirements.
- 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.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive).
- 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.
Key exclusion criteria (19 listed)
- Participants with a history of allergy to any component of the investigational product, or allergic diathesis (allergies to multiple drugs and foods).
- Participants unable to tolerate venous blood collection, or with a history of needle syncope or blood phobia.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GST-HG141GST-HG141 is a novel, potent and selective HBV CAM, which has a distinct molecular mechanism of its antiviral action compared to other CAMs reported in the literature, and has demonstrated strong antiviral properties in pre-clinical studies in vitro and in vivo. | Drug | Experimental |
| GST-HG131GST-HG131 is a novel dihydroquinolizinone (DHQ) compound, has been shown to reduce circulating levels of HBsAg in animals. | Drug | Experimental, Placebo 1, Placebo 2 |
| GST-HG141 PlaceboGST-HG141 Placebo | Drug | Placebo 1, Placebo 2 |
Primary outcome
HBsAg decline from baseline at D168
Time frame: : Baseline and up to 168 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GST-HG141 and GST-HG131 in people with Chronic Hepatitis B, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhang tianxiang (13247651892, zhangtianxiang@akeylink.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg decline from baseline at D168 (time frame: : Baseline and up to 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.