Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04147208
• Other study ID #: PCD-DGLS4-18-002
• Status: Recruiting
• Phase: Phase 2
• Start date: February 28, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: April 2023
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: junqi Niu, Doctor
• Phone: 13756661205
• Email: junqiniu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• 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

Related Conditions & MeSH terms

• Chronic HBV Infection
• Infections

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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