drugset / Trial / NCT04147208

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

NCT04147208 ↗

Phase 2 Completed 250 enrolled Sunshine Lake Pharma Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-02-28
Primary completion
2022-06-23
Completion
2023-09-14

Outcome

Met primary endpoint

paper The primary analysis at week 48 showed that the antiviral efficacy of GLS4/RTV with ETV was clearly superior to that of ETV monotherapy. PMID 39988055 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ETV Unknown 0.5 mg Oral
Subject GLS4 Other / unclassified 120 mg Oral
Subject RTV Unknown 100 mg Oral