MedTrace Logo

Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV

NCT03004625 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-01-09

No results posted yet for this study

Summary

A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.

Conditions

  • Hepatitis C

Interventions

DRUG

daclatasvir

to evaluate the treatment efficacy and safety of the drug in HCV patients

DRUG

asunaprevir

to evaluate the treatment efficacy and safety of the drug in HCV patients

DRUG

Ribavirin

to evaluate the treatment efficacy and safety of the drug in HCV patients

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • China Medical University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Ming-Lung Yu, MD., PhD. · Kaohsiung Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT03004625 on ClinicalTrials.gov