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

Last updated: June 20, 2024
Sponsor: Sunshine Lake Pharma Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Hepatitis B

Treatment

ETV

GLS4

RTV

Clinical Study ID

NCT04147208
PCD-DGLS4-18-002
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronic HBV infection population

  • HBeAg positive

  • HBsAg≥250 IU/mL

  • No cirrhosis

Exclusion

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 Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: ETV
Phase: 2
Study Start date:
February 28, 2019
Estimated Completion Date:
September 14, 2023

Study 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.

Connect with a study center

  • Beijing Ditan Hospital Affiliated to Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing YouAn Hospital,Capital Medical University

    Beijing, Beijing 100069
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • The first affiliated hospital of ChongQing medical university

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • The second affiliated hospital of ChongQing medical university

    Chongqing, Chongqing 400010
    China

    Site Not Available

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The third affiliated hospital of sun yat-sen university

    Guangzhou, Guangdong 510630
    China

    Site Not Available

  • The first affiliated hospital of Guangxi medical university

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Affiliated hospital of Guizhou medical university

    Guiyang, Guizhou 550001
    China

    Site Not Available

  • Affiliated hospital of ZunYi medical college

    Zunyi, Guizhou 563000
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Site Not Available

  • The fourth affiliated hospital of Harbin medical university

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The Central Hospital of Wuhan

    Wuhan, Hubei 430010
    China

    Site Not Available

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Nanjing Gulou Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • The People's Liberation Army No.81 Hospital

    Nanjing, Jiangsu 210002
    China

    Site Not Available

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu 210003
    China

    Site Not Available

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu 212004
    China

    Site Not Available

  • The first hospital of jilin university

    Chang chun, Jilin 130012
    China

    Site Not Available

  • The second hospital of jilin university

    Changchun, Jilin 130041
    China

    Site Not Available

  • Qingdao municipal hospital

    Qingdao, Shandong 266011
    China

    Site Not Available

  • Huashan Sub-Hospital of Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200020
    China

    Site Not Available

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai 201500
    China

    Site Not Available

  • Shanghai putuo district central hospital

    Shanghai, Shanghai 200062
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • The second affiliated hospital of air force medical university

    Xi'an, Shanxi 710038
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin third central hospital

    Tianjing, Tianjing 300170
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.