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Chronic HBV InfectionPhase 2NCT04147208

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

A Phase 2 study testing GLS4, RTV and ETV in people with Chronic HBV Infection, run by Sunshine Lake Pharma Co., Ltd. at 37 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic HBV Infection
What is being tested?
GLS4, RTV and ETV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
37 sitesChina
Study dates
28 Feb 2019to 14 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic HBV infection population
  • HBeAg positive
  • HBsAg≥250 IU/mL
  • No cirrhosis

Who cannot join

  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Beijing Ditan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing YouAn Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100069

  • The first hospital of jilin university

    Changchun, Jilin, 130012

  • The second hospital of jilin university

    Changchun, Jilin, 130041

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The second affiliated hospital of ChongQing medical university

    Chongqing, Chongqing Municipality, 400010

  • The first affiliated hospital of ChongQing medical university

    Chongqing, Chongqing Municipality, 400042

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The third affiliated hospital of sun yat-sen university

    Guangzhou, Guangdong, 510630

  • Affiliated hospital of Guizhou medical university

    Guiyang, Guizhou, 550001

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The fourth affiliated hospital of Harbin medical university

    Harbin, Heilongjiang, 150001

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The People's Liberation Army No.81 Hospital

    Nanjing, Jiangsu, 210002

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, 210003

  • Nanjing Gulou Hospital

    Nanjing, Jiangsu, 210008

  • The first affiliated hospital of Guangxi medical university

    Nanning, Guangxi, 530021

  • Qingdao municipal hospital

    Qingdao, Shandong, 266011

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

    Shanghai, Shanghai Municipality, 200020

  • Huashan Sub-Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai putuo district central hospital

    Shanghai, Shanghai Municipality, 200062

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 201500

  • Tianjin third central hospital

    Tianjing, Tianjing, 300170

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430010

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • The second affiliated hospital of air force medical university

    Xi’an, Shanxi, 710038

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu, 212004

  • Affiliated hospital of ZunYi medical college

    Zunyi, Guizhou, 563000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
GLS4, RTV, ETV
Keywords
Chronic HBeAg positive HBV Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLS4Drug

    Also called Morphothiadine Mesilate Capsules

    Administered GLS4 120 mg orally three times daily in fed state

  • RTVDrug

    Also called Ritonavir tablet

    Administered RTV 100 mg orally three times daily in fed state

  • ETVDrug

    Also called Entecavir table

    Administered orally ETV 0.5 mg once daily in fasted state

Study groups in NCT04147208
Study groupRoleWhat they receive
Combination groupExperimentalSubjects will receive 96 weeks of GLS4+RTV+ETV.
Receives: Drug: GLS4; Drug: RTV; Drug: ETV
Entecavir monotherapyActive comparatorSubjects received 96 weeks of entecavir treatment
Receives: Drug: ETV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The value of serum HBsAg decreased from baseline

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

    Measured: 48 weeks after dosing

Secondary outcomes (5)

  1. The value of serum HBeAg decreased from baseline

    The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline.

    Measured: 48 weeks after dosing

  2. The value of HBV DNA decreased from baseline

    The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.

    Measured: 48 weeks after dosing

  3. The value of serum HBsAg decreased from baseline

    The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.

    Measured: 24 weeks after dosing

  4. The value of serum HBeAg decreased from baseline

    The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.

    Measured: 24 weeks after dosing

  5. The value of HBV DNA decreased from baseline

    The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.

    Measured: 24 weeks after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start28 Feb 2019
  3. Primary completion23 Jun 2022
  4. Study completion14 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147208
Sponsor's protocol ID
PCD-DGLS4-18-002
Status last verified
Jun 2024
First submitted
28 Oct 2019
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang M, Gao Y, Kong F, Gao H, Yi Y, Wu C, Xin Y, Zheng S, Lu J, Han T, Zhao Y, Hu P, Mao X, Xie Q, Zhang J, Hou J, Gao Z, Lian J, Chen L, Shang J, Xie W, Mu M, Jin Z, Wang M, Lin S, Rao H, Yang D, Gong H, Luo L, Chen Y, Zhuang Y, Zhang Y, Gish RG, Tan Y, Zhang J, Niu J. Efficacy and safety of GLS4 with entecavir vs entecavir alone in chronic hepatitis B patients: A multicenter clinical trial. J Infect. 2025 Mar;90(3):106446. doi: 10.1016/j.jinf.2025.106446. Epub 2025 Feb 21.

    PubMed 39988055

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLS4, RTV and ETV in people with Chronic HBV Infection, run by Sunshine Lake Pharma Co., Ltd. at 37 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The value of serum HBsAg decreased from baseline (time frame: 48 weeks after dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04147208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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