Chronic HBV Infection Clinical Trial
Official title:
Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Combination With Entecavir in Comparison With Entecavir Alone in Patients With Chronic HBV Who Are HBeAg Positive
Verified date | June 2024 |
Source | Sunshine Lake Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | September 14, 2023 |
Est. primary completion date | June 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Chronic HBV infection population - HBeAg positive - HBsAg=250 IU/mL - No cirrhosis Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Ditan Hospital Affiliated to Capital Medical University | Beijing | Beijing |
China | Beijing YouAn Hospital,Capital Medical University | Beijing | Beijing |
China | Peking University People's Hospital | Beijing | Beijing |
China | The first hospital of jilin university | Chang chun | Jilin |
China | The second hospital of jilin university | Changchun | Jilin |
China | Xiangya Hospital, Central South University | Changsha | Hunan |
China | Sichuan Provincial People's Hospital | Chengdu | Sichuan |
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
China | The first affiliated hospital of ChongQing medical university | Chongqing | Chongqing |
China | The second affiliated hospital of ChongQing medical university | Chongqing | Chongqing |
China | Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian |
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 | Affiliated hospital of Guizhou medical university | Guiyang | Guizhou |
China | Hainan General Hospital | Haikou | Hainan |
China | The fourth affiliated hospital of Harbin medical university | Harbin | Heilongjiang |
China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
China | Nanjing Gulou Hospital | Nanjing | Jiangsu |
China | The People's Liberation Army No.81 Hospital | Nanjing | Jiangsu |
China | The Second Hospital of Nanjing | Nanjing | Jiangsu |
China | The first affiliated hospital of Guangxi medical university | Nanning | Guangxi |
China | Qingdao municipal hospital | Qingdao | Shandong |
China | Huashan Sub-Hospital of Fudan University | Shanghai | Shanghai |
China | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
China | Shanghai putuo district central hospital | Shanghai | Shanghai |
China | Tianjin third central hospital | Tianjing | Tianjing |
China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
China | The Central Hospital of Wuhan | Wuhan | Hubei |
China | Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology | Wuhan | Hubei |
China | Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
China | The second affiliated hospital of air force medical university | Xi'an | Shanxi |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
China | The Third People's Hospital of Zhenjiang | Zhenjiang | Jiangsu |
China | Affiliated hospital of ZunYi medical college | Zunyi | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | The value of HBV DNA decreased from baseline | The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline. | 48 weeks after dosing | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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