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ID

14052

Description

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

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  1. 3/23/16 3/23/16 -
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CC BY-NC 3.0

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March 23, 2016

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Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Biopsy

    English

    VX-950HPC3006 NCT01571583 Biopsy

    1 forms  
    Liver Graft Biopsy Result
    Description

    Liver Graft Biopsy Result

    Date of biopsy
    Description

    Date of biopsy

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005558
    UMLS CUI [1,2]
    C0011008
    liver fibrosis score (metavir)
    Description

    liver fibrosis score (metavir)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3897040
    Inflammation score (metavir)
    Description

    Inflammation score (metavir)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3888527
    Is there steatosis?
    Description

    If yes, please specify in the following item

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2711227
    Hepatic steatosis grade
    Description

    Hepatic steatosis grade

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2711227
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    Similar models

    VX-950HPC3006 NCT01571583 Biopsy

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Liver Graft Biopsy Result
    Item
    Date of biopsy
    integer
    C0005558 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of biopsy
    Code List
    Date of biopsy
    CL Item
    same date as visit date (1)
    CL Item
    other date, please specify: (2)
    Item
    liver fibrosis score (metavir)
    integer
    C3897040 (UMLS CUI [1])
    liver fibrosis score
    Code List
    liver fibrosis score (metavir)
    CL Item
    F0 (1)
    CL Item
    F1 (2)
    CL Item
    F2 (3)
    CL Item
    F3 (4)
    CL Item
    F4 (5)
    Item
    Inflammation score (metavir)
    integer
    C3888527 (UMLS CUI [1])
    Inflammation score (metavir)
    Code List
    Inflammation score (metavir)
    CL Item
    A0 (1)
    CL Item
    A1 (2)
    CL Item
    A2 (3)
    CL Item
    A3 (4)
    hepatic steatosis
    Item
    Is there steatosis?
    boolean
    C2711227 (UMLS CUI [1])
    Item
    Hepatic steatosis grade
    integer
    C2711227 (UMLS CUI [1])
    Hepatic steatosis grade
    Code List
    Hepatic steatosis grade
    CL Item
    less than 30% (1)
    CL Item
    30% to 60% (2)
    CL Item
    more than 60% (3)
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