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

Chronic HBV Infection Clinical Trial

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

Clinical 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04147208
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date February 28, 2019
Completion date September 14, 2023
View Details
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