Clinical trial NCT04147208: Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic HBV Infection
Keywords: Chronic HBeAg positive HBV Infection
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The value of serum HBsAg decreased from baseline
timeFrame: 48 weeks after dosing
Secondary outcomes:
measure: The value of serum HBeAg decreased from baseline
timeFrame: 48 weeks after dosing
measure: The value of HBV DNA decreased from baseline
timeFrame: 48 weeks after dosing
measure: The value of serum HBsAg decreased from baseline
timeFrame: 24 weeks after dosing
measure: The value of serum HBeAg decreased from baseline
timeFrame: 24 weeks after dosing
measure: The value of HBV DNA decreased from baseline
timeFrame: 24 weeks after dosing
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The second affiliated hospital of ChongQing medical university
state: Chongqing
city: Chongqing
country: China
facility: The first affiliated hospital of ChongQing medical university
state: Chongqing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The third affiliated hospital of sun yat-sen university
state: Guangdong
city: Nanning
country: China
facility: The first affiliated hospital of Guangxi medical university
state: Guangxi
city: Guiyang
country: China
facility: Affiliated hospital of Guizhou medical university
state: Guizhou
city: Zunyi
country: China
facility: Affiliated hospital of ZunYi medical college
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Harbin
country: China
facility: The fourth affiliated hospital of Harbin medical university
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: The People's Liberation Army No.81 Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Gulou Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: The Third People's Hospital of Zhenjiang
state: Jiangsu
city: Chang chun
country: China
facility: The first hospital of jilin university
state: Jilin
city: Changchun
country: China
facility: The second hospital of jilin university
state: Jilin
city: Qingdao
country: China
facility: Qingdao municipal hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Huashan Sub-Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai putuo district central hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Xi'an
country: China
facility: The second affiliated hospital of air force medical university
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjing
country: China
facility: Tianjin third central hospital
state: Tianjing
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The First Hospital of Jilin University
name: junqi Niu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: