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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06263959•Fujian Akeylink Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

35 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to sign the informed consent form，and fully understand the test content, process and possible adverse reactions；
•2. Males and females aged 35-65 ,able to complete research in accordance with test plan requirements;
•3. 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；
•4. 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；
•5. 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；
•6. At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ；
•7. HBeAg negative, 100≤HBsAg quantitative ≤1500 IU/mL, serum ALT\<1×ULN during screening;
•8. 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；
•9. Able to communicate well with clinical staff and complete the trial according to protocol requirements。

Exclusion Criteria

•1. Participants with a history of allergy to the any ingredient or excipients of the drug under study；
•2. Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting；
•3. Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study；
•4. 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；
•5. A history of alcohol or drug abuse or dependence；
•6. Participants have participated in clinical trials of drugs or medical devices (except in vitro diagnostic reagents) within 3 months prior to administration；
•7. Use of any hepatitis B drug other than NUC within 1 year prior to administration；
•8. 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；
•9. 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；
•10. 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);
+9 more criteria

Locations (1)

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, China

Key Dates

Start Date

December 26, 2023

Primary Completion Date

April 1, 2025

Completion Date

May 1, 2025

Last Updated

March 5, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Hepatitis B

Interventions

GST-HG131

DRUG

Placebo to match GST-HG131

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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