Chronic Hepatitis bPhase 3NCT07090759
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 study testing GST-HG141 in people with Chronic Hepatitis b, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- GST-HG141
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 526 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2025to 1 Mar 2027
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female individuals aged 18-70 years (inclusive of the boundaries);
- 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);
- 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
- HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA > 50 IU/mL;
- At the time of screening, ALT ≤ 5×ULN;
- 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 ;
- Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol.
Who cannot join
- 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;
- Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;
- 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;
- Presence of acute infections requiring treatment prior to randomization;
- 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;
- 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;
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- 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);
- 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.;
- 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.
- Subjects with major trauma or major surgery within 3 months prior to screening; or those who plan to undergo surgery during the study period;
- Laboratory tests:
- Platelet count < 100 × 109/L;
- White blood cell count < 3.0 × 109/L;
- Absolute neutrophil count < 1.3 × 109/L;
- Serum total bilirubin > 2× ULN;
- Albumin < 35 g/L;
- GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula);
- International normalized ratio (INR) of prothrombin time >1.5;
- Positive for hepatitis C antibody, positive for HIV antigen/antibody, or positive for syphilis antibody with a positive RPR or TRUST test result;
- 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);
- History of drug dependence or substance abuse;
- 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;
- Women who are breastfeeding or tested positive for pregnancy;
- Determined by the investigator to be unsuitable for this trial for any other reasons.
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
Shulan(Hangzhou) Hospital
Hangzhou, Zhejiang, 310011
Lanjuan Li, Dr., +86 571 5609 7873, ljli@zju.edu.cn
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)
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.
- Conditions
- Chronic Hepatitis b
- Being tested
- GST-HG141, 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 50 mg BID
GST-HG141 PlaceboDrug
GST-HG141 Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| GST-HG141 | Experimental | Not described Receives: Drug: GST-HG141 |
| GST-HG141 Placebo | Placebo comparator | Not described Receives: Drug: GST-HG141 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Up to 48 weeks
Secondary outcomes (1)
Serum HBV DNA
The changes of HBV DNA level compared to baseline;
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start24 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 526 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
- NCT07090759
- Sponsor's protocol ID
- GST-HG141-III-01
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)
- ClinicalTrials.gov ID
- NCT07090759
- Acronym / sponsor ID
- GST-HG141-III-01
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GST-HG141 | Experimental | Drug: GST-HG141 |
| GST-HG141 Placebo | Placebo comparator | Drug: GST-HG141 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female individuals aged 18-70 years (inclusive of the boundaries);
- 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);
- 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;
- HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA > 50 IU/mL;
- At the time of screening, ALT ≤ 5×ULN;
Key exclusion criteria (24 listed)
- 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;
- Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;
- 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;
- Presence of acute infections requiring treatment prior to randomization;
- 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;
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 50 mg BID | Drug | GST-HG141 |
| GST-HG141 PlaceboGST-HG141 Placebo BID | Drug | GST-HG141 Placebo |
Primary outcome
Proportion of participants with serum Hepatitis B Virus (HBV) DNA
Time frame: Up to 48 weeks
Proportion of participants with serum Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) treatment period;
1 secondary outcome
Serum HBV DNA
Time frame: Up to 48 weeks
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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 3 study testing GST-HG141 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 24 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 23 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yan wenhao, MD (17390087876, yanwenhao@akeylink.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with serum Hepatitis B Virus (HBV) DNA (time frame: Up to 48 weeks). 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 23 Jan 2026.