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ID

14060

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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Versions (1)
  1. 23/03/2016 23/03/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

23 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Unscheduled Assessment

    Anglais

    VX-950HPC3006 NCT01571583 Unscheduled Assessment

    1 Formulaires  
    Unscheduled Assessment
    Description

    Unscheduled Assessment

    Check the assessments to be completed at this unscheduled visit
    Description

    assessment at unscheduled visit

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [2,1]
    C0545082 (Visit)
    UMLS CUI [2,2]
    C3854240 (Unscheduled)
    SNOMED
    2341000175109
    LOINC
    LA22869-4
    Was a local lab done at this visit?
    Description

    (office use only)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [2]
    C0545082 (Visit)
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    Similar models

    VX-950HPC3006 NCT01571583 Unscheduled Assessment

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Unscheduled Assessment
    Item
    Check the assessments to be completed at this unscheduled visit
    integer
    C0220825 (UMLS CUI [1])
    C0545082 (UMLS CUI [2,1])
    C3854240 (UMLS CUI [2,2])
    assessment at unscheduled visit
    Code List
    Check the assessments to be completed at this unscheduled visit
    CL Item
    Vital signs / anthropometric measurements (1)
    CL Item
    12-lead electrocardiogram (2)
    CL Item
    physical examination (3)
    CL Item
    central laboratory (4)
    CL Item
    PK TVR (5)
    CL Item
    PK TAC/CsA (6)
    CL Item
    Biopsy (7)
    Item
    Was a local lab done at this visit?
    integer
    C0022877 (UMLS CUI [1])
    C0545082 (UMLS CUI [2])
    local lab
    Code List
    Was a local lab done at this visit?
    CL Item
    local laboratory - blood, urine and pregnancy (1)
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