0 Ratings
ID

42016

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

Keywords

Versions (2)
  1. 3/21/16 3/21/16 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 15, 2021

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License

Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Concomitant Therapy

    English

    VX-950HPC3006 NCT01571583 Concomitant Therapy

    1 forms  
    Concomitant Therapy
    Description

    Concomitant Therapy

    Alias
    UMLS CUI-1
    C1707479
    Therapy
    Description

    Therapy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0087111
    Indication or AE
    Description

    If AE associated with this CM, please complete the AE page and create an association with the corresponding AE

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3146298
    UMLS CUI [2]
    C0877248
    Prophylaxis
    Description

    Prophylaxis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0199176
    Dose per intake
    Description

    Dose per intake

    Data type

    text

    Alias
    UMLS CUI [1]
    C3174092
    unit
    Description

    Unit

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    frequency
    Description

    frequency

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3476109
    route of administration
    Description

    route of administration

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013153
    start of therapy
    Description

    start of therapy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3173309
    end of therapy
    Description

    please complete "ongoing" only at the end of the trial

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0444930
    row number
    Description

    (for office use only)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0237753
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    Similar models

    VX-950HPC3006 NCT01571583 Concomitant Therapy

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Concomitant Therapy
    C1707479 (UMLS CUI-1)
    Therapy
    Item
    Therapy
    text
    C0087111 (UMLS CUI [1])
    Item
    Indication or AE
    integer
    C3146298 (UMLS CUI [1])
    C0877248 (UMLS CUI [2])
    Indication or AE
    Code List
    Indication or AE
    CL Item
    indication please specify: (1)
    CL Item
    AE (2)
    Prophylaxis
    Item
    Prophylaxis
    boolean
    C0199176 (UMLS CUI [1])
    Dose per intake
    Item
    Dose per intake
    text
    C3174092 (UMLS CUI [1])
    Unit
    Item
    unit
    text
    C1519795 (UMLS CUI [1])
    Item
    frequency
    integer
    C3476109 (UMLS CUI [1])
    frequency
    Code List
    frequency
    CL Item
    q.d. - once daily (1)
    CL Item
    b.i.d. - twice daily (2)
    CL Item
    t.i.d. - three times daily (3)
    CL Item
    q.i.d. - four times daily (4)
    CL Item
    other, specify (5)
    Item
    route of administration
    integer
    C0013153 (UMLS CUI [1])
    route of administration
    Code List
    route of administration
    CL Item
    oral (1)
    CL Item
    other, specify (2)
    Item
    start of therapy
    integer
    C3173309 (UMLS CUI [1])
    start of therapy
    Code List
    start of therapy
    CL Item
    pre-trial (1)
    CL Item
    start date, please specify: (2)
    Item
    end of therapy
    integer
    C0087111 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    end of therapy
    Code List
    end of therapy
    CL Item
    end date, please specify (1)
    CL Item
    ongoing at end of the trial (2)
    row number
    Item
    row number
    text
    C0237753 (UMLS CUI [1])
    Back to the top of the page 

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