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EXPEDITION-1

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

    Status Completed
    Related Conditions
    Hepatitis C Virus Infection
    Chronic Hepatitis C
    Compensated Cirrhosis

Enrollment Details

146 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M14-172

Brief summary

Top

The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 5

0
Calgary, AB
1
Toronto, ON
2
Toronto, ON
3
Toronto, ON
4
Winnipeg, MB
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Study Design

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

    • Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 infection
    • Chronic HCV infection
    • Subject must be HCV treatment-naïve or have failed prior HCV treatment
    • Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease
    • Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus antibody
    • HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
    • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530

More on this trial

Clinical Trials.gov