CClinicalTrials.gg
RecruitingNCT07090759Updated Jan 23, 2026

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

A Phase 3 interventional study of GST-HG141 and GST-HG141 Placebo in Chronic Hepatitis b, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Fujian Akeylink Biotechnology Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
526
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Chronic Hepatitis b

Browse trials for

03

In context

Hepatitis B, Chronic

942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.

This study's planned enrollment of 526 is above the median of 100 across 683 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Fujian Akeylink Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 the range of 18-35 kg/m2 (inclusive of the boundaries);
  3. Have been continuously taking nucleoside analogues (entecavir [ETV], tenofovir disoproxil fumarate [TDF], emivirofavir [TMF], or propivirofavir [TAF]) for more than one year (with a break of less than one month in the past year), and are receiving treatment at the time of screening and agree to accept the treatment plan provided by this study during the study period;

    * Have maintained the same NA monotherapy for more than 3 months before screening

  4. HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA > 50 IU/mL;
  5. At the time of screening, ALT ≤ 5×ULN;
  6. Male participants with a fertile female partner or female participants of childbearing age who are willing to voluntarily take effective contraceptive measures from the time of screening until 28 days after the completion of the study ;
  7. Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol.

Exclusion criteria

Exclusion Criteria:

  1. History of life-threatening severe allergic reactions such as anaphylactic shock, or allergy to the active ingredients or excipients of the study drug as suspected by the investigator;
  2. Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;
  3. Systemic use of immunosuppressants, immunomodulators (interferon must be discontinued for more than 12 months), or cytotoxic drugs within 6 months prior to screening; or vaccination with live attenuated vaccines within 1 month prior to screening;
  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 the investigator;
  6. Subjects with a history of cirrhosis (e.g., subjects who have undergone pathological examination of liver tissue with a report indicating cirrhosis or those who have undergone endoscopy indicating esophageal or gastric varices); or subjects with currently diagnosed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal or gastric varices, splenomegaly, and ascites; or subjects with significant progression of liver fibrosis;
  7. Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 μg/L (or 20 ng/mL) or DCP>40 mAU/mL or imaging suggesting possible malignant lesions in the liver; concurrent other malignancies or history of other malignancies within the past 5 years (except for cured basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ);
  8. Presence of gastrointestinal impairment or gastrointestinal disease that may affect the absorption of oral medication in the judgment of the investigator, such as severe 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 the subject 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; or those who plan to undergo surgery during the study period;
  11. Laboratory tests:

    1. Platelet count \< 100 × 109/L;
    2. White blood cell count \< 3.0 × 109/L;
    3. Absolute neutrophil count \< 1.3 × 109/L;
    4. Serum total bilirubin > 2× ULN;
    5. Albumin \< 35 g/L;
    6. GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula);
    7. International normalized ratio (INR) of prothrombin time >1.5;
  12. Positive for hepatitis C antibody, positive for HIV antigen/antibody, or positive for syphilis antibody with a positive RPR or TRUST test result;
  13. 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 30 mL of spirits at 40% alcohol content);
  14. History of drug dependence or substance abuse;
  15. Participation in clinical trials involving other investigational drugs or medical devices and receiving the investigational drug or using the medical device within 3 months prior to screening;
  16. Women who are breastfeeding or tested positive for pregnancy;
  17. Determined by the investigator to be unsuitable for this trial for any other reasons.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
526 participants (estimated)

Study arms

  • Experimental
    GST-HG141

    Drug: GST-HG141

  • Placebo comparator
    GST-HG141 Placebo

    Drug: GST-HG141 Placebo

Interventions

  • DrugGST-HG141

    GST-HG141 50 mg BID

  • DrugGST-HG141 Placebo

    GST-HG141 Placebo BID

06

What researchers measure

Primary outcomes

  1. Proportion of participants with serum Hepatitis B Virus (HBV) DNA

    Proportion of participants with serum Hepatitis B Virus (HBV) DNA \< lower limit of quantification (LLOQ) treatment period;

    Time frame: Up to 48 weeks

Secondary outcomes

  1. Serum HBV DNA

    The changes of HBV DNA level compared to baseline;

    Time frame: Up to 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Shulan(Hangzhou) Hospital
    Hangzhou, Zhejiang 310011, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07090759
Lead sponsor
Fujian Akeylink Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Jul 29, 2025
Start date
Jul 24, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Jan 23, 2026

Study contacts

Yan wenhao, MD
Contact
yanwenhao@akeylink.cn
17390087876

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion