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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic HBV Infection

Intervention / Treatment
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* Drug: GLS4
* Drug: RTV
* Drug: ETV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination group<br>Subjects will receive 96 weeks of GLS4+RTV+ETV. | Drug: GLS4<br>* Administered GLS4 120 mg orally three times daily in fed state<br>* Other names: Morphothiadine Mesilate Capsules;Drug: RTV<br>* Administered RTV 100 mg orally three times daily in fed state<br>* Other names: Ritonavir tablet;Drug: ETV<br>* Administered orally ETV 0.5 mg once daily in fasted state<br>* Other names: Entecavir table;|
| Active Comparator: Entecavir monotherapy<br>Subjects received 96 weeks of entecavir treatment | Drug: ETV<br>* Administered orally ETV 0.5 mg once daily in fasted state<br>* Other names: Entecavir table;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of serum HBsAg decreased from baseline | The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline. | 48 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of serum HBeAg decreased from baseline | 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 | 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 | 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 | 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 | The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline. | 24 weeks after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic HBeAg positive HBV Infection