Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
- Registration Number
- NCT04147208
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Chronic HBV infection population
- HBeAg positive
- HBsAg≥250 IU/mL
- No cirrhosis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination group GLS4 Subjects will receive 96 weeks of GLS4+RTV+ETV. Combination group ETV Subjects will receive 96 weeks of GLS4+RTV+ETV. Entecavir monotherapy ETV Subjects received 96 weeks of entecavir treatment Combination group RTV Subjects will receive 96 weeks of GLS4+RTV+ETV.
- Primary Outcome Measures
Name Time Method The value of serum HBsAg decreased from baseline 48 weeks after dosing The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
- Secondary Outcome Measures
Name Time Method The value of HBV DNA decreased from baseline 24 weeks after dosing The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.
The value of serum HBeAg decreased from baseline 24 weeks after dosing The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.
The value of serum HBsAg decreased from baseline 24 weeks after dosing The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.
Trial Locations
- Locations (37)
Beijing Ditan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing YouAn Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
The second affiliated hospital of ChongQing medical university
🇨🇳Chongqing, Chongqing, China
The first affiliated hospital of ChongQing medical university
🇨🇳Chongqing, Chongqing, 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
Scroll for more (27 remaining)Beijing Ditan Hospital Affiliated to Capital Medical University🇨🇳Beijing, Beijing, China