Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
NCT ID: NCT04147208
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2019-02-28
2023-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination group
Subjects will receive 96 weeks of GLS4+RTV+ETV.
GLS4
Administered GLS4 120 mg orally three times daily in fed state
RTV
Administered RTV 100 mg orally three times daily in fed state
ETV
Administered orally ETV 0.5 mg once daily in fasted state
Entecavir monotherapy
Subjects received 96 weeks of entecavir treatment
ETV
Administered orally ETV 0.5 mg once daily in fasted state
Interventions
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GLS4
Administered GLS4 120 mg orally three times daily in fed state
RTV
Administered RTV 100 mg orally three times daily in fed state
ETV
Administered orally ETV 0.5 mg once daily in fasted state
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBeAg positive
* HBsAg≥250 IU/mL
* No cirrhosis
Exclusion Criteria
* Platelet count less than 90E+09/L
* TBil\>1.5×ULN
* albumin\<35 g/L
* INR\>1.5
* AFP\>50 ng/mL
18 Years
65 Years
ALL
No
Sponsors
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Sunshine Lake Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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junqi Niu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The second affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, China
The first affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The third affiliated hospital of sun yat-sen university
Guangzhou, Guangdong, China
The first affiliated hospital of Guangxi medical university
Nanning, Guangxi, China
Affiliated hospital of Guizhou medical university
Guiyang, Guizhou, China
Affiliated hospital of ZunYi medical college
Zunyi, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
The fourth affiliated hospital of Harbin medical university
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The People's Liberation Army No.81 Hospital
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Nanjing Gulou Hospital
Nanjing, Jiangsu, China
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
The first hospital of jilin university
Changchun, Jilin, China
The second hospital of jilin university
Changchun, Jilin, China
Qingdao municipal hospital
Qingdao, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Huashan Sub-Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai putuo district central hospital
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
The second affiliated hospital of air force medical university
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin third central hospital
Tianjing, Tianjing, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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References
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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.
Other Identifiers
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PCD-DGLS4-18-002
Identifier Type: -
Identifier Source: org_study_id
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