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ID

14114

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. 3/30/16 3/30/16 -
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CC BY-NC 3.0

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March 30, 2016

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Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

    English

    VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

    1 forms  
    Laboratory blood urine pregnancy
    Description

    Laboratory blood urine pregnancy

    Alias
    UMLS CUI-1
    C0022877
    date of collection
    Description

    date of collection

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516698
    UMLS CUI [1,2]
    C0011008
    if other date, please specify
    Description

    other date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0205394
    remarks regarding sample collection, if any
    Description

    remarks

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    clinically significant abnormalities?
    Description

    overall interpretation of laboratory report(s)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    central laboratory reference number
    Description

    sample reference numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826265
    UMLS CUI [1,2]
    C1880016
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    Similar models

    VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Laboratory blood urine pregnancy
    C0022877 (UMLS CUI-1)
    Item
    date of collection
    integer
    C1516698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    date of collection
    Code List
    date of collection
    CL Item
    same date as visit date (1)
    CL Item
    other date please specify (2)
    other date
    Item
    if other date, please specify
    date
    C0011008 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    remarks
    Item
    remarks regarding sample collection, if any
    text
    C0947611 (UMLS CUI [1])
    abnormality clinically significant
    Item
    clinically significant abnormalities?
    boolean
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    central laboratory reference number
    Item
    central laboratory reference number
    text
    C2826265 (UMLS CUI [1,1])
    C1880016 (UMLS CUI [1,2])
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