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To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients

NCT03593447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin

Group1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg

DRUG

non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin

Group2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg

DRUG

non-cirrhotic subjects. low TG-2349+ low DAG181

Group 3: TG-2349 200 mg + DAG181 100 mg

DRUG

non-cirrhotic subjects. high TG-2349+ high DAG181

Group 4: TG-2349 400 mg + DAG181 200 mg

DRUG

cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin

Group 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg\_

DRUG

cirrhotic subjects. high TG-2349+ high DAG181

Group6: TG-2349 400 mg + DAG181 200 mg

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lai Wei, MD · Peking University Peoples Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-04-23
Completion
2020-02-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593447 on ClinicalTrials.gov