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

Primary Purpose

Chronic Hepatitis b

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GST-HG141
Sponsored by
Fujian Akeylink Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring Chronic Hepatitis b

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The first hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low-dose group

High-dose group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum HBV DNA quantification
Changes in serum HBV DNA quantitative detection values from baseline

Full Information

First Posted
November 24, 2022
Last Updated
December 5, 2022
Sponsor
Fujian Akeylink Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05637541
Brief Title
Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Akeylink Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
Chronic Hepatitis b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-dose group
Arm Type
Experimental
Arm Description
Drug 1 is a vial of 130 tablets of the experimental drug, and drug 2 is a vial of 130 tablets of the placebo
Arm Title
High-dose group
Arm Type
Experimental
Arm Description
Drug 1 and 2 are each a vial of 130 tablets of the experimental drug
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Drug 1 and drug 2 are each a vial of 130 tablets of the placebo
Intervention Type
Drug
Intervention Name(s)
GST-HG141
Intervention Description
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
Primary Outcome Measure Information:
Title
Serum HBV DNA
Description
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.
Time Frame
12 or 24 weeks
Secondary Outcome Measure Information:
Title
Serum HBV DNA quantification
Description
Changes in serum HBV DNA quantitative detection values from baseline
Time Frame
12 or 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanan Tang MD
Phone
+8613585734994
Email
annie_tyn@163.com
Facility Information:
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, Dr.
Phone
+86-13756661205
Email
junqiniu@aliyun.com
First Name & Middle Initial & Last Name & Degree
Ding

12. IPD Sharing Statement

Plan to Share IPD
No

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

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