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

Sponsor

Fujian Akeylink Biotechnology Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05637541

Collaborator

(none)

Enrollment

Location

Arms

13.2

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Drug: GST-HG141	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Nov 23, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose group Drug 1 is a vial of 130 tablets of the experimental drug, and drug 2 is a vial of 130 tablets of the placebo	Drug: GST-HG141 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
Experimental: High-dose group Drug 1 and 2 are each a vial of 130 tablets of the experimental drug	Drug: GST-HG141 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
Placebo Comparator: Placebo group Drug 1 and drug 2 are each a vial of 130 tablets of the placebo	Drug: GST-HG141 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

Arm

Intervention/Treatment

Experimental: Low-dose group

Drug 1 is a vial of 130 tablets of the experimental drug, and drug 2 is a vial of 130 tablets of the placebo

Drug: GST-HG141

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

Experimental: High-dose group

Drug 1 and 2 are each a vial of 130 tablets of the experimental drug

Drug: GST-HG141

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

Placebo Comparator: Placebo group

Drug 1 and drug 2 are each a vial of 130 tablets of the placebo

Drug: GST-HG141

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

Outcome Measures

Primary Outcome Measures

Serum HBV DNA [12 or 24 weeks]
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.

Secondary Outcome Measures

Serum HBV DNA quantification [12 or 24 weeks]
Changes in serum HBV DNA quantitative detection values from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.