Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
1 other identifier
interventional
250
1 country
37
Brief Summary
The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2019
CompletedFirst Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2023
CompletedJune 21, 2024
June 1, 2024
3.3 years
October 28, 2019
June 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The value of serum HBsAg decreased from baseline
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
48 weeks after dosing
Secondary Outcomes (5)
The value of serum HBeAg decreased from baseline
48 weeks after dosing
The value of HBV DNA decreased from baseline
48 weeks after dosing
The value of serum HBsAg decreased from baseline
24 weeks after dosing
The value of serum HBeAg decreased from baseline
24 weeks after dosing
The value of HBV DNA decreased from baseline
24 weeks after dosing
Study Arms (2)
Combination group
EXPERIMENTALSubjects will receive 96 weeks of GLS4+RTV+ETV.
Entecavir monotherapy
ACTIVE COMPARATORSubjects received 96 weeks of entecavir treatment
Interventions
Administered GLS4 120 mg orally three times daily in fed state
Administered RTV 100 mg orally three times daily in fed state
Administered orally ETV 0.5 mg once daily in fasted state
Eligibility Criteria
You may qualify if:
- Chronic HBV infection population
- HBeAg positive
- HBsAg≥250 IU/mL
- No cirrhosis
You may not qualify if:
- AST\>5×ULN
- Platelet count less than 90E+09/L
- TBil\>1.5×ULN
- albumin\<35 g/L
- INR\>1.5
- AFP\>50 ng/mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069, China
The second affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, 400010, China
The first affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, 400042, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510060, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The third affiliated hospital of sun yat-sen university
Guangzhou, Guangdong, 510630, China
The first affiliated hospital of Guangxi medical university
Nanning, Guangxi, 530021, China
Affiliated hospital of Guizhou medical university
Guiyang, Guizhou, 550001, China
Affiliated hospital of ZunYi medical college
Zunyi, Guizhou, 563000, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The fourth affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430010, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
The People's Liberation Army No.81 Hospital
Nanjing, Jiangsu, 210002, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003, China
Nanjing Gulou Hospital
Nanjing, Jiangsu, 210008, China
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, 212004, China
The first hospital of jilin university
Changchun, Jilin, 130012, China
The second hospital of jilin university
Changchun, Jilin, 130041, China
Qingdao municipal hospital
Qingdao, Shandong, 266011, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Huashan Sub-Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai putuo district central hospital
Shanghai, Shanghai Municipality, 200062, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201500, China
The second affiliated hospital of air force medical university
Xi’an, Shanxi, 710038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin third central hospital
Tianjing, Tianjing, 300170, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
Zhang M, Gao Y, Kong F, Gao H, Yi Y, Wu C, Xin Y, Zheng S, Lu J, Han T, Zhao Y, Hu P, Mao X, Xie Q, Zhang J, Hou J, Gao Z, Lian J, Chen L, Shang J, Xie W, Mu M, Jin Z, Wang M, Lin S, Rao H, Yang D, Gong H, Luo L, Chen Y, Zhuang Y, Zhang Y, Gish RG, Tan Y, Zhang J, Niu J. Efficacy and safety of GLS4 with entecavir vs entecavir alone in chronic hepatitis B patients: A multicenter clinical trial. J Infect. 2025 Mar;90(3):106446. doi: 10.1016/j.jinf.2025.106446. Epub 2025 Feb 21.
PMID: 39988055DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
junqi Niu, Doctor
The First Hospital of Jilin University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
November 1, 2019
Study Start
February 28, 2019
Primary Completion
June 23, 2022
Study Completion
September 14, 2023
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share