Clinical trial NCT03593447: To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients
Official title: A Multicenter, Randomized, Open-label, Dose-ranging, Phase II Study to Evaluate the Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in Treatment naïve Subjects With Chronic Hepatic C Virus Genotype I Infection
Conditions: Chronic Hepatics C Virus (HCV) Genotype 1
Non-Cirrhotic
Cirrhosis
Treatment naïve
Summary: A phase II study to evaluate the efficacy and safety in TG-2349 combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection.
Interventions:
description: Group1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg
name: non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin
type: Drug
description: Group2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg
name: non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
type: Drug
description: Group 3: TG-2349 200 mg + DAG181 100 mg
name: non-cirrhotic subjects. low TG-2349+ low DAG181
type: Drug
description: Group 4: TG-2349 400 mg + DAG181 200 mg
name: non-cirrhotic subjects. high TG-2349+ high DAG181
type: Drug
description: Group 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg_
name: cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
type: Drug
description: Group6: TG-2349 400 mg + DAG181 200 mg
name: cirrhotic subjects. high TG-2349+ high DAG181
type: Drug
Study arms:
design_group_description: HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. low dose TG-2349+ low dose DAG181+Ribavirin
design_group_title: non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin
design_group_type: Experimental
design_group_description: HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. high dose TG-2349+ high dose DAG181+Ribavirin
design_group_title: non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
design_group_type: Experimental
design_group_description: HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. low dose TG-2349+ low dose DAG181
design_group_title: non-cirrhotic subjects. low TG-2349+ low DAG181
design_group_type: Experimental
design_group_description: HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. high dose TG-2349+ high dose DAG181
design_group_title: non-cirrhotic subjects. high TG-2349+ high DAG181
design_group_type: Experimental
design_group_description: HCV genotype 1 infected, treatment naïve, cirrhotic subjects. high dose TG-2349+ high dose DAG181+Ribavirin
design_group_title: cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
design_group_type: Experimental
design_group_description: HCV genotype 1 infected, treatment naïve, cirrhotic subjects. high dose TG-2349+ high dose DAG181
design_group_title: cirrhotic subjects. high TG-2349+ high DAG181
design_group_type: Experimental
Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Collaborators: Peking University People's Hospital
Drug name mappings:
name: 磷酸依米他韦
lang: CN
name: Emitasvir Phosphate
lang: EN
name: 伏拉瑞韦
lang: CN
name: Furaprevir
lang: EN
name: 利巴韦林
lang: CN
name: Ribavirin
lang: EN
name: リバビリン
lang: JP