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

Sunshine Lake Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic HBV Infection

Treatments: Drug: RTV; Drug: ETV; Drug: GLS4

Study type: Interventional

Funder types: Industry

Identifiers

NCT04147208

PCD-DGLS4-18-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Combination group

Experimental group

Description:

Subjects will receive 96 weeks of GLS4+RTV+ETV.

Treatment:

Drug: GLS4

Drug: ETV

Drug: RTV

Entecavir monotherapy

Active Comparator group

Description:

Subjects received 96 weeks of entecavir treatment

Treatment:

Drug: ETV