Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
About 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.At the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect HBV DNA, cccDNA, HBsAg, and evaluate the degree of liver inflammation and fibrosis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination group | Experimental | Subjects will receive 96 weeks of GLS4+RTV+ETV. |
|
| Entecavir monotherapy | Active Comparator | Subjects received 96 weeks of entecavir treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS4 | Drug | Administered GLS4 120 mg orally three times daily in fed state |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The value of serum HBeAg decreased from baseline | The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline. | 48 weeks after dosing |
| The value of HBV DNA decreased from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| junqi Niu, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100020 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39988055 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RTV | Drug | Administered RTV 100 mg orally three times daily in fed state |
|
|
| ETV | Drug | Administered orally ETV 0.5 mg once daily in fasted state |
|
|
The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.
| 48 weeks after dosing |
| The value of serum HBsAg decreased from baseline | The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline. | 24 weeks after dosing |
| The value of serum HBeAg decreased from baseline | The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline. | 24 weeks after dosing |
| The value of HBV DNA decreased from baseline | The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline. | 24 weeks after dosing |
| 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 |
| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided