0 Bedömningar
ID

16752

Beskrivning

Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00160251

Länk

https://clinicaltrials.gov/show/NCT00160251

Nyckelord

Versioner (1)
  1. 2016-08-03 2016-08-03 -
Uppladdad den

3 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Chronic Hepatitis C NCT00160251

    Engelsk

    Eligibility Chronic Hepatitis C NCT00160251

    1 Formulär  
    Criteria
    Beskrivning

    Criteria

    documented infection with chronic hepatitis c (chc), genotype 1.
    Beskrivning

    chronic hepatitis c (chc), genotype 1

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C4049392
    documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in hcv-rna after 12 weeks of therapy or those who never become hepatitis c virus ribonucleic acid (hcv)-rna negative)
    Beskrivning

    failure to respond to an adequate course of treatment with peginterferon-alfa plus ribavirin

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162643
    UMLS CUI [1,2]
    C0919875
    UMLS CUI [1,3]
    C1875630
    no evidence of cirrhosis on liver biopsy.
    Beskrivning

    no evidence of cirrhosis on liver biopsy.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023890
    UMLS CUI [1,2]
    C0193388
    results of physical examination and laboratory tests within specified ranges.
    Beskrivning

    results of physical examination and laboratory tests within specified ranges

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0459422
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C0459422
    abstinence from use of abused substances.
    Beskrivning

    abstinence from use of abused substances

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843422
    UMLS CUI [1,2]
    C0687130
    key exclusion criteria:
    Beskrivning

    exclusion criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    women who are pregnant or nursing a child.
    Beskrivning

    pregnant or breastfeeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    patients with cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients (by protocol amendment 2, african-american patients can enroll).
    Beskrivning

    cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023890
    UMLS CUI [2,1]
    C0275524
    UMLS CUI [2,2]
    C0019682
    UMLS CUI [3,1]
    C0275524
    UMLS CUI [3,2]
    C0019163
    UMLS CUI [4]
    C0085756
    previous treatment with any hepatitis c virus (hcv) polymerase or protease inhibitor.
    Beskrivning

    hepatitis c virus (hcv) polymerase or protease inhibitor

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196
    UMLS CUI [1,2]
    C2746051
    UMLS CUI [2,1]
    C0019196
    UMLS CUI [2,2]
    C0033607
    patients who relapsed following response to previous treatment.
    Beskrivning

    relapse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    evidence of advanced liver disease, or liver disease from a cause other than chc.
    Beskrivning

    advanced liver disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0860197
    UMLS CUI [2]
    C0009488
    pre-existing psychiatric condition.
    Beskrivning

    psychiatric condition

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936
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    Similar models

    Eligibility Chronic Hepatitis C NCT00160251

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    chronic hepatitis c (chc), genotype 1
    Item
    documented infection with chronic hepatitis c (chc), genotype 1.
    boolean
    C4049392 (UMLS CUI [1])
    failure to respond to an adequate course of treatment with peginterferon-alfa plus ribavirin
    Item
    documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in hcv-rna after 12 weeks of therapy or those who never become hepatitis c virus ribonucleic acid (hcv)-rna negative)
    boolean
    C0162643 (UMLS CUI [1,1])
    C0919875 (UMLS CUI [1,2])
    C1875630 (UMLS CUI [1,3])
    no evidence of cirrhosis on liver biopsy.
    Item
    no evidence of cirrhosis on liver biopsy.
    boolean
    C0023890 (UMLS CUI [1,1])
    C0193388 (UMLS CUI [1,2])
    results of physical examination and laboratory tests within specified ranges
    Item
    results of physical examination and laboratory tests within specified ranges.
    boolean
    C0031809 (UMLS CUI [1,1])
    C0459422 (UMLS CUI [1,2])
    C0022885 (UMLS CUI [2,1])
    C0459422 (UMLS CUI [2,2])
    abstinence from use of abused substances
    Item
    abstinence from use of abused substances.
    boolean
    C3843422 (UMLS CUI [1,1])
    C0687130 (UMLS CUI [1,2])
    exclusion criteria
    Item
    key exclusion criteria:
    boolean
    C0680251 (UMLS CUI [1])
    pregnant or breastfeeding
    Item
    women who are pregnant or nursing a child.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients
    Item
    patients with cirrhosis, co-infection with hepatitis b or human immunodeficiency virus (hiv), and african-american patients (by protocol amendment 2, african-american patients can enroll).
    boolean
    C0023890 (UMLS CUI [1])
    C0275524 (UMLS CUI [2,1])
    C0019682 (UMLS CUI [2,2])
    C0275524 (UMLS CUI [3,1])
    C0019163 (UMLS CUI [3,2])
    C0085756 (UMLS CUI [4])
    hepatitis c virus (hcv) polymerase or protease inhibitor
    Item
    previous treatment with any hepatitis c virus (hcv) polymerase or protease inhibitor.
    boolean
    C0019196 (UMLS CUI [1,1])
    C2746051 (UMLS CUI [1,2])
    C0019196 (UMLS CUI [2,1])
    C0033607 (UMLS CUI [2,2])
    relapse
    Item
    patients who relapsed following response to previous treatment.
    boolean
    C0277556 (UMLS CUI [1])
    advanced liver disease
    Item
    evidence of advanced liver disease, or liver disease from a cause other than chc.
    boolean
    C0860197 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    psychiatric condition
    Item
    pre-existing psychiatric condition.
    boolean
    C0004936 (UMLS CUI [1])
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