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ClinicalTrials.gov Identifier: NCT02692703

A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)

    Status Active, not recruiting
    Related Conditions
    Chronic Hepatitis C
    HCV
    Hepatitis C Virus

Enrollment Details

100 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M13-596

Brief summary

Top

The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 in adults who are post primary orthotopic liver or renal transplant with chronic Hepatitis C Virus infection.

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

Canada: 2

0
Edmonton, AB
1
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

    • Male or female, at least 18 years of age at time of screening.
    • Screening laboratory result indicating HCV GT1 - 6 infection.
    • Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection at least 3 months prior to screening Or Subject received a cadaveric or living donor kidney at least 3 months before screening.
    • Subjects must be documented as non-cirrhotic.
    • Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil, azathioprine, and/or cyclosporine.
    • Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
    • Clinical history of fibrosing cholestatic hepatitis post-transplant.
    • Re-transplantation of the liver or kidney.
    • Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
    • History of post-transplant complications related to hepatic or renal vasculature.

More on this trial

Clinical Trials.gov