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ENDURANCE-3

A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

    Status Completed
    Related Conditions
    Chronic Hepatitis C
    Hepatitis C Virus
    Genotype 3 Hepatitis C Virus

Enrollment Details

506 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M13-594

Brief summary

Top

The purpose of this study is to compare the safety and efficacy of ABT-493/ABT-530 to the combination of Sofosbuvir (SOF) and Daclatasvir (DCV) in adults with genotype 3 chronic hepatitis C virus (HCV) infection.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 100 Years

Canada: 4

0
Montreal, QC
1
Toronto, ON
2
Vancouver, BC
3
Winnipeg, MB
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
    ?

    Allocation

    Randomized

  • 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.
    ?

    Intervention Model

    Parallel Assignment

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

    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

    • Screening laboratory result indicating HCV GT3 infection
    • Chronic HCV infection
    • Subject must be treatment-naïve
    • Subjects must be non-cirrhotic
    • History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
    • 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 one HCV genotype.

More on this trial

Clinical Trials.gov