search
Back to results

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

Primary Purpose

Chronic HBV Infection

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GLS4
RTV
ETV
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic HBV Infection focused on measuring Chronic HBeAg positive HBV Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Ditan Hospital Affiliated to Capital Medical UniversityRecruiting
  • Peking University People's HospitalRecruiting
  • Beijing YouAn Hospital,Capital Medical UniversityRecruiting
  • The second affiliated hospital of ChongQing medical universityRecruiting
  • The first affiliated hospital of ChongQing medical universityRecruiting
  • Mengchao Hepatobiliary Hospital of Fujian Medical UniversityRecruiting
  • The First Hospital of Lanzhou UniversityRecruiting
  • Guangzhou Eighth People's HospitalRecruiting
  • Nanfang Hospital of Southern Medical UniversityRecruiting
  • The third affiliated hospital of sun yat-sen universityRecruiting
  • The first affiliated hospital of Guangxi medical universityRecruiting
  • Affiliated hospital of Guizhou medical universityRecruiting
  • Affiliated hospital of ZunYi medical collegeRecruiting
  • Hainan General HospitalRecruiting
  • The fourth affiliated hospital of Harbin medical universityRecruiting
  • Henan Provincial People's HospitalRecruiting
  • The Central Hospital of WuhanRecruiting
  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & TechnologyRecruiting
  • Xiangya Hospital, Central South UniversityRecruiting
  • The People's Liberation Army No.81 HospitalRecruiting
  • The Second Hospital of NanjingRecruiting
  • Nanjing Gulou HospitalRecruiting
  • The Third People's Hospital of ZhenjiangRecruiting
  • The first hospital of jilin universityRecruiting
  • The second hospital of jilin universityRecruiting
  • Qingdao municipal hospitalRecruiting
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Huashan Sub-Hospital of Fudan UniversityRecruiting
  • Shanghai putuo district central hospitalRecruiting
  • Shanghai Public Health Clinical CenterRecruiting
  • The second affiliated hospital of air force medical universityRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Sichuan Provincial People's HospitalRecruiting
  • Tianjin third central hospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination group

Entecavir monotherapy

Arm Description

Subjects will receive 96 weeks of GLS4+RTV+ETV.

Subjects received 96 weeks of entecavir treatment

Outcomes

Primary Outcome Measures

The value of serum HBsAg decreased from baseline
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.

Secondary Outcome Measures

The value of serum HBeAg decreased from baseline
The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline.
The value of HBV DNA decreased from baseline
The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.
The value of serum HBsAg decreased from baseline
The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.
The value of serum HBeAg decreased from baseline
The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.
The value of HBV DNA decreased from baseline
The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.

Full Information

First Posted
October 28, 2019
Last Updated
April 11, 2023
Sponsor
Sunshine Lake Pharma Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04147208
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HBV Infection
Keywords
Chronic HBeAg positive HBV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination group
Arm Type
Experimental
Arm Description
Subjects will receive 96 weeks of GLS4+RTV+ETV.
Arm Title
Entecavir monotherapy
Arm Type
Active Comparator
Arm Description
Subjects received 96 weeks of entecavir treatment
Intervention Type
Drug
Intervention Name(s)
GLS4
Other Intervention Name(s)
Morphothiadine Mesilate Capsules
Intervention Description
Administered GLS4 120 mg orally three times daily in fed state
Intervention Type
Drug
Intervention Name(s)
RTV
Other Intervention Name(s)
Ritonavir tablet
Intervention Description
Administered RTV 100 mg orally three times daily in fed state
Intervention Type
Drug
Intervention Name(s)
ETV
Other Intervention Name(s)
Entecavir table
Intervention Description
Administered orally ETV 0.5 mg once daily in fasted state
Primary Outcome Measure Information:
Title
The value of serum HBsAg decreased from baseline
Description
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
Time Frame
48 weeks after dosing
Secondary Outcome Measure Information:
Title
The value of serum HBeAg decreased from baseline
Description
The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline.
Time Frame
48 weeks after dosing
Title
The value of HBV DNA decreased from baseline
Description
The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.
Time Frame
48 weeks after dosing
Title
The value of serum HBsAg decreased from baseline
Description
The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.
Time Frame
24 weeks after dosing
Title
The value of serum HBeAg decreased from baseline
Description
The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.
Time Frame
24 weeks after dosing
Title
The value of HBV DNA decreased from baseline
Description
The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.
Time Frame
24 weeks after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
junqi Niu, Doctor
Phone
13756661205
Email
junqiniu@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
mingyuan Zhang
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
junqi Niu, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Xie
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiying Rao
Facility Name
Beijing YouAn Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujun Zheng
Facility Name
The second affiliated hospital of ChongQing medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Hu
Facility Name
The first affiliated hospital of ChongQing medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxiang Huang
Facility Name
Mengchao Hepatobiliary Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghua Lin
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaorong Mao
Facility Name
Guangzhou Eighth People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuchun Zhang
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou
Facility Name
The third affiliated hospital of sun yat-sen university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiliang Gao
Facility Name
The first affiliated hospital of Guangxi medical university
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianning Jiang
Facility Name
Affiliated hospital of Guizhou medical university
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuang Lu
Facility Name
Affiliated hospital of ZunYi medical college
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shide Lin
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Lin
Facility Name
The fourth affiliated hospital of Harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liying Zhu
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Shang
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Zhang
Facility Name
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongliang Yang
Facility Name
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huanyu Gong
Facility Name
The People's Liberation Army No.81 Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maorong Wang
Facility Name
The Second Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongxiang Yi
Facility Name
Nanjing Gulou Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Wu
Facility Name
The Third People's Hospital of Zhenjiang
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youwen Tan
Facility Name
The first hospital of jilin university
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
junqi Niu
Facility Name
The second hospital of jilin university
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengjing Jin
Facility Name
Qingdao municipal hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongning Xin
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Xie
Facility Name
Huashan Sub-Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiming Zhang
Facility Name
Shanghai putuo district central hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhang
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Chen
Facility Name
The second affiliated hospital of air force medical university
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhansheng Jia
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingren Zhao
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia jie Lu
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingxiang Yang
Facility Name
Tianjin third central hospital
City
Tianjing
State/Province
Tianjing
ZIP/Postal Code
300170
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Han
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Chen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs