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Chronic Hepatitis bPhase 2NCT05637541

Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets

A Phase 2 study testing GST-HG141 in people with Chronic Hepatitis b, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
3 Jan 2023to 24 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
  • Ability to complete research in accordance with test plan requirements;
  • Subjects (including partners) are willing to take effective pregnancy avoidance measures within 28 days after screening to the last study drug administration;
  • Male and female subjects aged between 18 and 70 years old (both inclusive);
  • The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), and the body mass index is within the range of 18-35 kg / m2 (including the critical value);
  • Have been taking a nucleoside analogue (entecavir [ETV], tenofovir dipiroxide fumarate [TDF], or profotenofovir [TAF]) for 1 to 3 years, were receiving treatment at the time of screening and agreed to receive the treatment offered in this study during the study;
  • Serum HBV DNA could be detected by high-sensitivity PCR with a dose of 20 IU/ ml < HBV DNA < 2000 IU/mL;
  • Screening, ALT ≤ 5 x ULN and liver stiffness testing (LSM) meet the following requirements: ALT≤ 2 x ULN, LSM≤10.6 kPa; Or 2 x ULN≤ ALT≤ 5×ULN ，LSM< 12.4 kPa.

Who cannot join

  • Patients with a history of allergy or suspected allergy to the active ingredient or excipients of the drug under study;
  • Concomitant use of an inhibitor, inducer, or substrate of the cytochrome P450 enzyme 3A4 isoenzyme (CYP3A4) within 28 days before screening；
  • Patients 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;
  • Acute infection requiring treatment with intravenous antibiotics within 2 weeks before screening or current infection requiring antiinfective treatment;
  • Patients 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;
  • 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); Or currently confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, hemorrhage of esophageal and fundus varices, spleen enlargement, ascites, etc.; Or there is evidence of progressive hepatic fibrosis;
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  • Primary liver cancer; Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) or imaging suggest possible malignant liver placeholder; Patients with other malignant tumors or a history of other malignant tumors within 5 years before screening (except cured basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ);
  • The presence of impaired gastrointestinal function or gastrointestinal disease that may affect oral drug absorption, such as severe gastrointestinal disease (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, and screening. Grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea)；
  • Patients with severe circulatory, respiratory, urinary, blood, metabolic, immune, mental, nervous, renal and other diseases were judged by the researchers to be unsuitable for this study；
  • Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study;
  • 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;
  • Hepatitis C antibody positive, AIDS antigen/antibody positive, treponema pallidum antibody positive and rapid plasma reagin test (RPR) positive;
  • 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 before screening；
  • A history of continuous alcohol abuse (drinking > 14 alcohol units per week, defined as 1 alcohol unit for a 350ml bottle of beer, 120ml of wine, or 30ml of 40% spirits) within 3 years before screening;
  • A history of drug dependence or abuse;
  • Participants who participated in clinical trials of investigational drugs or medical devices within 3 months before screening and took investigational drugs or used medical devices;
  • Breastfeeding women or those who have a positive pregnancy test;
  • The investigator believes that there are other subjects who are not suitable for participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia

A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia.

Read the detailed description

This study was a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of different doses of GST-HG141 in treated CHB patients with low viremia.

A total of 90 CHB patients with low viremia after hepatitis B antiviral therapy were enrolled in this study, and they were divided into three groups, 30 cases in each group. Screening of eligible subjects, according to the proportion were randomly assigned to: GST - HG141 low dose group, the GST - HG141 high dose group and the placebo group.

Being tested
GST-HG141
Keywords
Chronic Hepatitis b
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

    The trial consisted of a low-dose group and a high-dose group, each of which was 50mg bid and 100mg bid for 12 or 24 weeks of treatment

Study groups in NCT05637541
Study groupRoleWhat they receive
Low-dose groupExperimentalDrug 1 is a vial of 130 tablets of the experimental drug, and drug 2 is a vial of 130 tablets of the placebo
Receives: Drug: GST-HG141
High-dose groupExperimentalDrug 1 and 2 are each a vial of 130 tablets of the experimental drug
Receives: Drug: GST-HG141
Placebo groupPlacebo comparatorDrug 1 and drug 2 are each a vial of 130 tablets of the placebo
Receives: Drug: GST-HG141

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum HBV DNA

    At the end of treatment, serum HBV DNA was lower than the lower limit of quantitative detection value (HBV DNA ≤ 20 IU/mL)percentage of subjects.

    Measured: 12 or 24 weeks

Secondary outcomes (1)

  1. Serum HBV DNA quantification

    Changes in serum HBV DNA quantitative detection values from baseline

    Measured: 12 or 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start3 Jan 2023
  3. Primary completion24 Jul 2024
  4. Study completion24 Aug 2024

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637541
Sponsor's protocol ID
GST-HG141-Ⅱ-02
Status last verified
Aug 2024
First submitted
24 Nov 2022
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang C, Kong F, Gao H, Cai D, Zhang G, Ning Q, Zhong B, Liu Z, Su Z, Wu G, Hou J, Mao J, Zhang T, Wu W, Yan W, Yan X, Li G, Gao Y, Zhang G, Niu J. Safety and efficacy of GST-HG141, a novel HBV capsid assembly modulator, for the treatment of chronic hepatitis B patients with low-level viremia: a randomized, double-blind, placebo-controlled, multicenter phase II study. EClinicalMedicine. 2025 Aug 2;87:103400. doi: 10.1016/j.eclinm.2025.103400. eCollection 2025 Sep.

    PubMed 40808966

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 18 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: finished, as of the sponsor's last update on 5 Mar 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum HBV DNA (time frame: 12 or 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05637541, which also lists 1 linked publication.

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 5 Mar 2025.

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