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ClinicalTrial.gov Identifier : NCT01715415

A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

    Status Completed
    Related Conditions
    Chronic Hepatitis C Infection

Enrollment Details

394 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Brief summary

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A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 70 Years

Canada: 4

0
Calgary, AB
1
Ottawa, ON
2
Toronto, ON
3
Vancouver, BC
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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.
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    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.
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    Masking

    Double Blind (Subject, Investigator)

  • 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

    • Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.
    • Chronic hepatitis C, genotype 1 infection (HCV RNA level greater than 10,000 IU/mL at screening).
    • Failed previous treatment with pegIFN and RBV.
    • No evidence of liver cirrhosis.

     

    • Positive screen for drugs or alcohol.
    • Significant sensitivity to any drug.
    • Use of contraindicated medications within 2 weeks of dosing.
    • Abnormal laboratory tests.
    • Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody.

More on this trial

Clinical Trials.gov