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

Last updated: March 3, 2025
Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

GST-HG141

Clinical Study ID

NCT05637541
GST-HG141-Ⅱ-02
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign the informed consent before the trial and fully understand the content, processand possible adverse reactions of the trial;

  2. Ability to complete research in accordance with test plan requirements;

  3. Subjects (including partners) are willing to take effective pregnancy avoidancemeasures within 28 days after screening to the last study drug administration;

  4. Male and female subjects aged between 18 and 70 years old (both inclusive);

  5. The weight of male subjects shall not be less than 50kg and that of female subjectsshall 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 thecritical value);

  6. Have been taking a nucleoside analogue (entecavir [ETV], tenofovir dipiroxidefumarate [TDF], or profotenofovir [TAF]) for 1 to 3 years, were receiving treatmentat the time of screening and agreed to receive the treatment offered in this studyduring the study;

  7. Serum HBV DNA could be detected by high-sensitivity PCR with a dose of 20 IU/ ml <HBV DNA < 2000 IU/mL;

  8. Screening, ALT ≤ 5 x ULN and liver stiffness testing (LSM) meet the followingrequirements: ALT≤ 2 x ULN, LSM≤10.6 kPa; Or 2 x ULN≤ ALT≤ 5×ULN ,LSM< 12.4 kPa.

Exclusion

Exclusion Criteria:

  1. Patients with a history of allergy or suspected allergy to the active ingredient orexcipients of the drug under study;

  2. Concomitant use of an inhibitor, inducer, or substrate of the cytochrome P450 enzyme 3A4 isoenzyme (CYP3A4) within 28 days before screening;

  3. Patients with systemic use of immunosuppressants, immunomodulators (excludinginterferon) and cytotoxic drugs within 6 months before screening; Or those whoreceived live attenuated vaccine within 1 month before screening;

  4. Acute infection requiring treatment with intravenous antibiotics within 2 weeksbefore screening or current infection requiring antiinfective treatment;

  5. Patients with clinically significant acute or chronic liver disease caused bynon-HBV infection who were judged by the investigator to be unsuitable for thestudy;

  6. A history of cirrhosis (e.g., the subject had a histopathological examination of theliver and reported cirrhosis, or had an endoscopic examination indicating varicoseesophagus and fundus veins); Or currently confirmed or suspected decompensatedcirrhosis, including but not limited to: hepatic encephalopathy, hepatorenalsyndrome, hemorrhage of esophageal and fundus varices, spleen enlargement, ascites,etc.; Or there is evidence of progressive hepatic fibrosis;

  7. Primary liver cancer; Serum AFP (AFP) is greater than 50 ㎍ / L (or 50 ng/mL) orimaging suggest possible malignant liver placeholder; Patients with other malignanttumors or a history of other malignant tumors within 5 years before screening (except cured basal cell or squamous cell carcinoma of the skin and cervicalcarcinoma in situ);

  8. The presence of impaired gastrointestinal function or gastrointestinal disease thatmay affect oral drug absorption, such as severe gastrointestinal disease (pepticulcer, erosive or atrophic gastritis), partial gastrectomy, and screening. Grade 2gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea);

  9. Patients with severe circulatory, respiratory, urinary, blood, metabolic, immune,mental, nervous, renal and other diseases were judged by the researchers to beunsuitable for this study;

  10. Patients with major trauma or major surgery within 3 months before screening; orplan to have surgery during the study;

  11. Laboratory examination: platelet count < 90 x 10^9 / L; White blood cell count <3.0x 10^9 / L; Neutrophils absolute value< 1.3 x 10^9 / L; Serum total bilirubin >2 xULN. Albumin< 30 g/L; Creatinine clearance ≤ 60 mL/min or less; Prothrombin timeinternational standardization ratio (INR) >1.5;

  12. Hepatitis C antibody positive, AIDS antigen/antibody positive, treponema pallidumantibody positive and rapid plasma reagin test (RPR) positive;

  13. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or receivedblood transfusion; Or blood donation or blood loss ≥200 mL within 1 month beforescreening;

  14. A history of continuous alcohol abuse (drinking > 14 alcohol units per week, definedas 1 alcohol unit for a 350ml bottle of beer, 120ml of wine, or 30ml of 40% spirits)within 3 years before screening;

  15. A history of drug dependence or abuse;

  16. Participants who participated in clinical trials of investigational drugs or medicaldevices within 3 months before screening and took investigational drugs or usedmedical devices;

  17. Breastfeeding women or those who have a positive pregnancy test;

  18. The investigator believes that there are other subjects who are not suitable forparticipating in this trial.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: GST-HG141
Phase: 2
Study Start date:
January 03, 2023
Estimated Completion Date:
August 24, 2024

Study 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.

Connect with a study center

  • The first hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

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