AzTrials
AzTrials

Chronic Hepatitis BPhase 2NCT06263959

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 Phase 2 study testing GST-HG131 in people with Chronic Hepatitis B, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
GST-HG131
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteChina
Study dates
26 Dec 2023to 1 May 2025
Phase
Phase 2
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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to sign the informed consent form，and fully understand the test content, process and possible adverse reactions；
  • Males and females aged 35-65 ,able to complete research in accordance with test plan requirements;
  • 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；
  • 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；
  • 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；
  • At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ；
Show all 9Show fewer
  • HBeAg negative, 100≤HBsAg quantitative ≤1500 IU/mL, serum ALT<1×ULN during screening;
  • 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；
  • Able to communicate well with clinical staff and complete the trial according to protocol requirements。

Who cannot join

  • Participants with a history of allergy to the any ingredient or excipients of the drug under study；
  • Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting；
  • Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study；
  • 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；
  • A history of alcohol or drug abuse or dependence；
  • Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration；
Show all 19Show fewer
  • Use of any hepatitis B drug other than NUC within 1 year prior to administration；
  • 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；
  • 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；
  • 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);
  • 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；
  • 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)；
  • 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)；
  • Participants with suspected or confirmed acute infections within 2 weeks prior to randomization；
  • 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；
  • Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) or imaging suggest possible malignant liver placeholder；
  • Hepatitis C antibody positive, treponema pallidum antibody positive and rapid plasma reagin test (RPR) positive,AIDS antigen/antibody positive；
  • Breastfeeding women or those who have a positive pregnancy test at screening or baseline；
  • 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. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing

    Tang Yanan, +8613585734994, annie_tyn@163.com

    Recruiting

Other trials in China

About this study

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

Being tested
GST-HG131, Placebo to match GST-HG131
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-HG131Drug

    GST-HG131 will be administered.

  • Placebo to match GST-HG131Drug

    Placebo to match GST-HG131 will be administered.

Study groups in NCT06263959
Study groupRoleWhat they receive
Cohort 1ExperimentalPatiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 1) or placebo for 28 days.
Receives: Drug: GST-HG131; Drug: Placebo to match GST-HG131
Cohort 2ExperimentalPatiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 2) or placebo for 28 days.
Receives: Drug: GST-HG131; Drug: Placebo to match GST-HG131
Cohort 3ExperimentalPatiants on stable nucleos(t)ide analog (NA) therapy will be randomized 4:1 to receive repeat dose of either GST-HG131 (Dose 1 or 2) or placebo for 12 weeks.
Receives: Drug: GST-HG131; Drug: Placebo to match GST-HG131

What is being measured

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

  1. Change from Baseline in HBsAg levels

    Change from Baseline in HBsAg levels

    Measured: Baseline and up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3)

Secondary outcomes (1)

  1. Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs

    Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs

    Measured: Up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3)

Timeline

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

  1. First posted16 Feb 2024
  2. Study start26 Dec 2023
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06263959
Sponsor's protocol ID
GST-HG131-II-01
Status last verified
Mar 2025
First submitted
7 Jan 2024
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Guo Y, Xu Z, Li Y, Mao J, Zhang T, Li Y, Meng F, Fu J, Ji D, Ji Y, Cheng Y, Zhang M, Zhang X, Sun Y, Huang Z, Cai D, Wu W, Yan W, Yan X, Li G, Hou J, Zhang G, Wang FS. Safety, Tolerability and Antiviral Activity of GST-HG131 in Chronic Hepatitis B: A Randomized, Double-Blind Phase IIa Study. Liver Int. 2026 Nov;46(11):e70918. doi: 10.1111/liv.70918.

    PubMed 42865026

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GST-HG131 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 9 inclusion and 19 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 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. 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in HBsAg levels (time frame: Baseline and up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3)). 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 NCT06263959, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in