To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment

Last updated: January 22, 2026
Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

GST-HG141 Placebo

GST-HG141

Clinical Study ID

NCT07090759
GST-HG141-III-01
  • Ages 18-70
  • All Genders

Study Summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female individuals aged 18-70 years (inclusive of the boundaries);

  2. Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within therange of 18-35 kg/m2 (inclusive of the boundaries);

  3. Have been continuously taking nucleoside analogues (entecavir [ETV], tenofovirdisoproxil fumarate [TDF], emivirofavir [TMF], or propivirofavir [TAF]) for morethan one year (with a break of less than one month in the past year), and arereceiving treatment at the time of screening and agree to accept the treatment planprovided by this study during the study period;

  • Have maintained the same NA monotherapy for more than 3 months before screening
  1. HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA > 50 IU/mL;

  2. At the time of screening, ALT ≤ 5×ULN;

  3. Male participants with a fertile female partner or female participants ofchildbearing age who are willing to voluntarily take effective contraceptivemeasures from the time of screening until 28 days after the completion of the study ;

  4. Sign the informed consent form before the trial and be able to complete the study asrequired by the trial protocol.

Exclusion

Exclusion Criteria:

  1. History of life-threatening severe allergic reactions such as anaphylactic shock, orallergy to the active ingredients or excipients of the study drug as suspected bythe investigator;

  2. Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, orsubstrates within 28 days prior to screening;

  3. Systemic use of immunosuppressants, immunomodulators (interferon must bediscontinued for more than 12 months), or cytotoxic drugs within 6 months prior toscreening; or vaccination with live attenuated vaccines within 1 month prior toscreening;

  4. Presence of acute infections requiring treatment prior to randomization;

  5. Clinically significant acute or chronic liver disease not caused by HBV infection,rendering the subject unsuitable for participating in the study as determined by theinvestigator;

  6. Subjects with a history of cirrhosis (e.g., subjects who have undergone pathologicalexamination of liver tissue with a report indicating cirrhosis or those who haveundergone endoscopy indicating esophageal or gastric varices); or subjects withcurrently diagnosed or suspected decompensated cirrhosis, including but not limitedto: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal orgastric varices, splenomegaly, and ascites; or subjects with significant progressionof liver fibrosis;

  7. Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 μg/L (or 20ng/mL) or DCP>40 mAU/mL or imaging suggesting possible malignant lesions in theliver; concurrent other malignancies or history of other malignancies within thepast 5 years (except for cured basal cell carcinoma or squamous cell carcinoma ofthe skin and cervical carcinoma in situ);

  8. Presence of gastrointestinal impairment or gastrointestinal disease that may affectthe absorption of oral medication in the judgment of the investigator, such assevere gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis),partial gastrectomy, Grade > 2 gastrointestinal symptoms at screening (e.g., nausea,vomiting, or diarrhea), etc.;

  9. Concurrent severe diseases of the circulatory, respiratory, urinary, hematologic,metabolic, immune, psychiatric, neurological, renal, or other systems, rendering thesubject unsuitable for participating in the study as determined by the investigator.

  10. Subjects with major trauma or major surgery within 3 months prior to screening; orthose who plan to undergo surgery during the study period;

  11. Laboratory tests:

  12. Platelet count < 100 × 109/L;

  13. White blood cell count < 3.0 × 109/L;

  14. Absolute neutrophil count < 1.3 × 109/L;

  15. Serum total bilirubin > 2× ULN;

  16. Albumin < 35 g/L;

  17. GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula);

  18. International normalized ratio (INR) of prothrombin time >1.5;

  19. Positive for hepatitis C antibody, positive for HIV antigen/antibody, or positivefor syphilis antibody with a positive RPR or TRUST test result;

  20. History of sustained alcohol abuse within the past 3 years (weekly alcohol intake > 14 units, where 1 unit of alcohol equals 1 bottle of 350 mL beer, 120 mL wine, or 30mL of spirits at 40% alcohol content);

  21. History of drug dependence or substance abuse;

  22. Participation in clinical trials involving other investigational drugs or medicaldevices and receiving the investigational drug or using the medical device within 3months prior to screening;

  23. Women who are breastfeeding or tested positive for pregnancy;

  24. Determined by the investigator to be unsuitable for this trial for any otherreasons.

Study Design

Total Participants: 526
Treatment Group(s): 2
Primary Treatment: GST-HG141 Placebo
Phase: 3
Study Start date:
July 24, 2025
Estimated Completion Date:
March 01, 2027

Study Description

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.

This research project enrolled a total of 526 CHB patients who have an inadequate response to hepatitis B antiviral treatment. They were divided into two groups, with 263 patients in each group.

The qualified participants were randomly assigned to the GST-HG141 group and the placebo group at a ratio of 1:1.

Connect with a study center

  • Shulan(Hangzhou) Hospital

    Hangzhou, Zhejiang 310011
    China

    Site Not Available

  • Shulan(Hangzhou) Hospital

    Hangzhou 1808926, Zhejiang 1784764 310011
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.