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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 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 Tablets in Patients With Chronic Hepatitis B (NCT06263959) is a Phase 2 interventional studying Chronic Hepatitis B, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Hepatitis B and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 45 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to sign the willing to sign a consent form form,and fully understand the test content, process and possible adverse reactions; 2. Males and females aged 35-65 ,able to complete research in accordance with test plan requirements; 3. Participants who have no childbearing plan in next 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. The weight of male patients shall not be less than 50 kg, and the weight of female patients is not less than 45 kg. Body mass index (BMI = weight (kg)/height 2 (m2)) in the range of 18.0\~35.0 kg/m2; 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. 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 quantitative ≤1500 IU/mL, serum ALT\<1×ULN during screening; 8. The normal or abnormal results of vital signs assessment, physical examination and 12-lead electrocardiogram during the screening period and baseline period have no clinical significance; 9. Able to communicate well with clinical staff and complete the trial according to protocol requirements。 Who Should NOT Join This Trial: 1. Participants with a history of allergy to the any ingredient or excipients of the drug under study; 2. Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting; 3. Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study; 4. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or received blood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior to screening; 5. A history of alcohol or drug abuse or dependence; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 ,able to complete research in accordance with test plan requirements; 3. Participants who have no childbearing plan in next 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. The weight of male patients shall not be less than 50 kg, and the weight of female patients is not less than 45 kg. Body mass index (BMI = weight (kg)/height 2 (m2)) in the range of 18.0\~35.0 kg/m2; 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. 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 quantitative ≤1500 IU/mL, serum ALT\<1×ULN during screening; 8. The normal or abnormal results of vital signs assessment, physical examination and 12-lead electrocardiogram during the screening period and baseline period have no clinical significance; 9. 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 the any ingredient or excipients of the drug under study; 2. Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting; 3. Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study; 4. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or received blood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior to screening; 5. A history of alcohol or drug abuse or dependence; 6. Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration; 7. Use of any hepatitis B drug other than NUC within 1 year prior to administration; 8. Participants with systemic use of immunosuppressants, immunomodulators (excluding interferon) and cytotoxic drugs within 6 months before screening; Or those who received live attenuated vaccine within 1 month before screening; 9. Participants with clinically significant acute or chronic liver disease caused by non-HBV infection who were judged by the investigator to be unsuitable for the study; 10. Participants with a history of cirrhosis (e.g., the subject had a histopathological examination of the liver and reported cirrhosis, or had an endoscopic examination indicating varicose esophagus and fundus veins); 11. Participants with hepatitis B cirrhosis in the confirmed or suspected decompensated stage, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophageal and fundus variceal bleeding, spleen enlargement, ascites, primary liver cancer, etc; 12. Participants with malignancy or history of other malignancies within 5 years prior to screening (except cured basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix); 13. The investigators determined the presence of impaired gastrointestinal function or gastrointestinal disease that might affect oral drug absorption, such as severe gastrointestinal disease (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, and gastrointestinal symptoms \> grade 2 at the time of screening (e.g., nausea, vomiting, or diarrhea); 14. Participants with suspected or confirmed acute infections within 2 weeks prior to randomization; 15. Laboratory examination: platelet count \< 90 x 10\^9 / L; White blood cell count \<3.0 x 10\^9 / L; Neutrophils absolute value\< 1.3 x 10\^9 / L; Serum total bilirubin \>2 x ULN. Albumin\< 30 g/L; Creatinine clearance ≤ 60 mL/min or less; Prothrombin time international standardization ratio (INR) \>1.5; 16. Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) or imaging suggest possible malignant liver placeholder; 17. Hepatitis C antibody positive, treponema pallidum antibody positive and rapid plasma reagin test (RPR) positive,AIDS antigen/antibody positive; 18. Breastfeeding women or those who have a positive pregnancy test at screening or baseline; 19. The investigator believes that there are other subjects who are not suitable for participating in this trial.

Treatments Being Tested

DRUG

GST-HG131

GST-HG131 will be administered.

DRUG

Placebo to match GST-HG131

Placebo to match GST-HG131 will be administered.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Fifth Medical Center of Chinese PLA General Hospital
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06263959), the sponsor (Fujian Akeylink Biotechnology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06263959 clinical trial studying?

A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06263959?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06263959?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06263959. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06263959. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.