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MALACHITE 1

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before.

    Status Completed
    Related Conditions
    Chronic Hepatitis C Infection

Enrollment Details

311 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M13-774

Brief summary

Top

This is a study to evaluate the efficacy and safety of three experimental drugs compared with Telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 65 Years

Canada: 3

0
Vancouver, BC
1
Vaughan, ON
2
Victoria, 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

  • 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

    Parallel 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

    • Males or females between 18 and 65 years, inclusive, at time of Screening.
    • Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
    • Subject has never received antiviral treatment for hepatitis C infection.
    • Chronic HCV Genotype-1 infection prior to study enrollment.
    • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
    • Positive screen for drugs or alcohol.
    • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
    • Females who are pregnant or plan to become pregnant, or breastfeeding
    • Any current or past clinical evidence of cirrhosis
    • Screening laboratory analyses that show abnormal laboratory results
    • Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for Telaprevir, PegIFN and RBV

More on this trial

Clinical Trials.gov