0 Bedömningar
ID

14044

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2016-03-23 2016-03-23 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

23 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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    VX-950HPC3006 NCT01571583 Study Drug Termination Telaprevir

    Engelsk

    VX-950HPC3006 NCT01571583 Study Drug Termination Telaprevir

    1 Formulär  
    Study Drug Completion/Discontinuation
    Beskrivning

    Study Drug Completion/Discontinuation

    Completed
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0205197
    Early drug discontinuation without trial termination due to an Adverse Event related event (including abnormal lab values, intercurrent illness and pregnancy), please specify AE#(s) - as recorded on AE form:
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0558681
    UMLS CUI [1,2]
    C1279919
    UMLS CUI [2]
    C0877248
    UMLS CUI [3]
    C2718058
    Discontinued, subject non-compliant
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2]
    C1444662
    Discontinued, subject ineligible to continue the protocol treatment
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1444662
    UMLS CUI [2]
    C1512714
    Discontinued, subject reached a virologic endpoint
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1444662
    UMLS CUI [2,1]
    C2349179
    UMLS CUI [2,2]
    C0205466
    Other reason, specify:
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3840932
    Early trial termination due to reasons other than listed above
    Beskrivning

    Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2718058
    UMLS CUI [2]
    C3840932
    Tillbaka till toppen

    Similar models

    VX-950HPC3006 NCT01571583 Study Drug Termination Telaprevir

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Study Drug Completion/Discontinuation
    Completed
    Item
    Completed
    boolean
    C0205197 (UMLS CUI [1])
    Early drug discontinuation
    Item
    Early drug discontinuation without trial termination due to an Adverse Event related event (including abnormal lab values, intercurrent illness and pregnancy), please specify AE#(s) - as recorded on AE form:
    text
    C0558681 (UMLS CUI [1,1])
    C1279919 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2])
    C2718058 (UMLS CUI [3])
    Discontinued, subject non-compliant
    Item
    Discontinued, subject non-compliant
    boolean
    C1321605 (UMLS CUI [1])
    C1444662 (UMLS CUI [2])
    Discontinued, subject ineligible to continue the protocol treatment
    Item
    Discontinued, subject ineligible to continue the protocol treatment
    boolean
    C1444662 (UMLS CUI [1])
    C1512714 (UMLS CUI [2])
    Discontinued, subject reached a virologic endpoint
    Item
    Discontinued, subject reached a virologic endpoint
    boolean
    C1444662 (UMLS CUI [1])
    C2349179 (UMLS CUI [2,1])
    C0205466 (UMLS CUI [2,2])
    Other reason
    Item
    Other reason, specify:
    text
    C3840932 (UMLS CUI [1])
    Early trial termination
    Item
    Early trial termination due to reasons other than listed above
    boolean
    C2718058 (UMLS CUI [1])
    C3840932 (UMLS CUI [2])
    Tillbaka till toppen 

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