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ID

42013

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

Mots-clés

  1. 21/03/2016 21/03/2016 -
  2. 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

15 mars 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    VX-950HPC3006 NCT01571583 Administration of TAC/CsA

    VX-950HPC3006 NCT01571583 Administration of TAC/CsA

    Administration of TAC/CsA
    Description

    Administration of TAC/CsA

    therapy
    Description

    therapy

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0087111
    UMLS CUI [2]
    C0085149
    UMLS CUI [3]
    C0010592
    Dose per intake
    Description

    Dose per intake

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3174092
    unit
    Description

    Unit

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1519795
    frequency
    Description

    frequency

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3476109
    route of administration
    Description

    route of administration

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0013153
    start of therapy
    Description

    start of therapy

    Type de données

    date

    Alias
    UMLS CUI [1]
    C3173309
    end of therapy
    Description

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

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0444930
    reason for change
    Description

    reason for change

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1299575
    UMLS CUI [1,2]
    C1272707
    row number
    Description

    row number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0237753

    Similar models

    VX-950HPC3006 NCT01571583 Administration of TAC/CsA

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administration of TAC/CsA
    Item
    therapy
    integer
    C0087111 (UMLS CUI [1])
    C0085149 (UMLS CUI [2])
    C0010592 (UMLS CUI [3])
    Code List
    therapy
    CL Item
    Tacrolimus (1)
    CL Item
    Cyclosporin A (2)
    Dose per intake
    Item
    Dose per intake
    text
    C3174092 (UMLS CUI [1])
    Item
    unit
    integer
    C1519795 (UMLS CUI [1])
    Code List
    unit
    CL Item
    mg (1)
    CL Item
    other please specify (2)
    frequency
    Item
    frequency
    text
    C3476109 (UMLS CUI [1])
    Item
    route of administration
    integer
    C0013153 (UMLS CUI [1])
    Code List
    route of administration
    CL Item
    oral (1)
    CL Item
    other specify (2)
    start of therapy
    Item
    start of therapy
    date
    C3173309 (UMLS CUI [1])
    Item
    end of therapy
    integer
    C0087111 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    Code List
    end of therapy
    CL Item
    end date please specify (1)
    CL Item
    ongoing at end of the trial (2)
    Item
    reason for change
    integer
    C1299575 (UMLS CUI [1,1])
    C1272707 (UMLS CUI [1,2])
    Code List
    reason for change
    CL Item
    PK (1)
    CL Item
    AE (2)
    CL Item
    Other please specify (3)
    row number
    Item
    row number
    text
    C0237753 (UMLS CUI [1])

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