0 Bewertungen
ID

16752

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00160251

Stichworte

Versionen (1)
  1. 8/3/16 8/3/16 -
Hochgeladen am

August 3, 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Eligibility Chronic Hepatitis C NCT00160251

    Englisch

    Eligibility Chronic Hepatitis C NCT00160251

    1 Formulare  
    Criteria
    Beschreibung

    Criteria

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

    chronic hepatitis c (chc), genotype 1

    Datentyp

    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)
    Beschreibung

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

    Datentyp

    boolean

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

    no evidence of cirrhosis on liver biopsy.

    Datentyp

    boolean

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

    results of physical examination and laboratory tests within specified ranges

    Datentyp

    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.
    Beschreibung

    abstinence from use of abused substances

    Datentyp

    boolean

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

    exclusion criteria

    Datentyp

    boolean

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

    pregnant or breastfeeding

    Datentyp

    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).
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    hepatitis c virus (hcv) polymerase or protease inhibitor

    Datentyp

    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.
    Beschreibung

    relapse

    Datentyp

    boolean

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

    advanced liver disease

    Datentyp

    boolean

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

    psychiatric condition

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Chronic Hepatitis C NCT00160251

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video