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ClinicalTrials.gov Identifier: NCT02636595

The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

    Status Completed
    Related Conditions
    Hepatitis C Virus

Enrollment Details

121 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M13-583

Brief summary

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The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

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

Canada: 3

0
Montreal, QC
1
Ottawa, ON
2
Toronto, ON
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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.
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    Purpose

    Treatment

    1. Screening laboratory result indicating HCV GT4, 5, or 6 infection.
    2. Chronic HCV infection.
    3. HCV treatment-naïve or treatment experienced (IFN or pegIFN with or without RBV; SOF plus RBV with or without pegIFN).
    4. Non-cirrhotic participants.
    1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
    2. 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.
    3. 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.
    4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
    5. Co-infection with more than one HCV genotype.

More on this trial

Clinical Trials.gov