NCT04147208

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	GLS4	Administered GLS4 120 mg orally three times daily in fed state
DRUG	RTV	Administered RTV 100 mg orally three times daily in fed state
DRUG	ETV	Administered orally ETV 0.5 mg once daily in fasted state

Timeline

• Start date: 2019-02-28
• Primary completion: 2022-06-23
• Completion: 2023-09-14
• First posted: 2019-11-01
• Last updated: 2024-06-21

Locations

37 sites across 1 country: China