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EXPEDITION-4

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection

    Status Completed
    Related Conditions
    Chronic Hepatitis C Virus (HCV) Infection

Enrollment Details

104 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M15-462

Brief summary

Top

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic renal impairment.

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

Canada: 6

0
Halifax, NS
1
London, ON
2
Montreal, QC
3
Montreal, QC
4
Toronto, ON
5
Vancouver, BC
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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

  • Chronic hepatitis C virus (HCV) infection

    • Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
    • Subject must be HCV treatment-naïve or have failed previous HCV treatment.
    • Subjects with underlying chronic renal impairment
    • Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

    History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.

    • Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
    • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
    • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
    • HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype.

More on this trial

Clinical Trials.gov