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

  • STATUS
    Recruiting
  • End date
    Oct 24, 2022
  • participants needed
    250
  • sponsor
    Sunshine Lake Pharma Co., Ltd.
Updated on 24 January 2021

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.

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.

Details
Condition Chronic HBV Infection
Treatment RTV, GLS4, ETV
Clinical Study IdentifierNCT04147208
SponsorSunshine Lake Pharma Co., Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Chronic HBV infection population
HBeAg positive
HBsAg250 IU/mL
No cirrhosis

Exclusion Criteria

AST>5ULN
Platelet count less than 90E+09/L
TBil>1.5ULN
albumin<35 g/L
INR>1.5
AFP>50 ng/mL
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