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

June 20, 2024 updated by: Sunshine Lake Pharma Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: mingyuan Zhang

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100069
        • Beijing Youan Hospital,Capital Medical University
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Ditan Hospital Affiliated to Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 400042
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The third affiliated hospital of Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510060
        • Guangzhou Eighth People's Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Affiliated Hospital of Guizhou Medical University
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital of Zunyi Medical College
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430010
        • The Central Hospital of Wuhan
      • Wuhan, Hubei, China, 430022
        • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital, Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • The Second Hospital of Nanjing
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Gulou Hospital
      • Nanjing, Jiangsu, China, 210002
        • The People's Liberation Army No.81 Hospital
      • Zhenjiang, Jiangsu, China, 212004
        • The Third People's Hospital of Zhenjiang
    • Jilin
      • Chang chun, Jilin, China, 130012
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Qingdao Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200020
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200062
        • Shanghai Putuo District Central Hospital
      • Shanghai, Shanghai, China, 201500
        • Shanghai Public Health Clinical Center
      • Shanghai, Shanghai, China, 200040
        • Huashan Sub-Hospital of Fudan University
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shanxi, China, 710038
        • The Second Affiliated Hospital of Air Force Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital
    • Tianjing
      • Tianjing, Tianjing, China, 300170
        • Tianjin Third Central Hospital
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combination group
Subjects will receive 96 weeks of GLS4+RTV+ETV.
Drug: GLS4
Administered GLS4 120 mg orally three times daily in fed state
Other Names:
  • Morphothiadine Mesilate Capsules
Drug: RTV
Administered RTV 100 mg orally three times daily in fed state
Other Names:
  • Ritonavir tablet
Drug: ETV
Administered orally ETV 0.5 mg once daily in fasted state
Other Names:
  • Entecavir table
Active Comparator: Entecavir monotherapy
Subjects received 96 weeks of entecavir treatment
Drug: ETV
Administered orally ETV 0.5 mg once daily in fasted state
Other Names:
  • Entecavir table

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The value of serum HBsAg decreased from baseline
Time Frame: 48 weeks after dosing
The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.
48 weeks after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The value of serum HBeAg decreased from baseline
Time Frame: 48 weeks after dosing
The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline.
48 weeks after dosing
The value of HBV DNA decreased from baseline
Time Frame: 48 weeks after dosing
The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.
48 weeks after dosing
The value of serum HBsAg decreased from baseline
Time Frame: 24 weeks after dosing
The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.
24 weeks after dosing
The value of serum HBeAg decreased from baseline
Time Frame: 24 weeks after dosing
The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.
24 weeks after dosing
The value of HBV DNA decreased from baseline
Time Frame: 24 weeks after dosing
The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.
24 weeks after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Lake Pharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: junqi Niu, Doctor, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCD-DGLS4-18-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings