NCT04155515

A Phase III Study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and RBV for HCV Type I Patients

A Phase III, Multicenter, Open-labeded Study To Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 Weeks of Treatment in HCV Genotype I Infected Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase III, Multicenter, open-labeded study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I Infected Patients

Detailed description

The purpose of this study is to evaluate efficacy and safety of TG-2349 in combination with DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I infected patients. Approximately 360 subjects will be enrolled in this study and divided into 2 groups: Group 1: Chronic hepatics C virus (HCV) genotype 1 infected, non-cirrhotic subjects. Group 2: Chronic hepatics C virus (HCV) genotype 1 infected, cirrhotic subjects.

Conditions

• Chronic Hepatics C Virus (HCV) Genotype 1
• Non-Cirrhotic
• Cirrhosis
• Treatment naïve

Interventions

Type	Name	Description
DRUG	TG-2349	TG-2349 400mg
DRUG	DAG181	DAG181 200mg
DRUG	Ribavirin	Ribavirin 1000mg/1200mg

Timeline

• Start date: 2019-06-13
• Primary completion: 2020-08-11
• Completion: 2020-08-11
• First posted: 2019-11-07
• Last updated: 2021-02-04

Locations

1 site across 1 country: China