Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
NCT04147208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2024-06-21
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.
Conditions
- Chronic HBV Infection
Interventions
- 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
Sponsors & Collaborators
-
Sunshine Lake Pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
junqi Niu, Doctor · The First Hospital of Jilin University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-28
- Primary Completion
- 2022-06-23
- Completion
- 2023-09-14
Countries
- China
Study Locations
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