0 Beoordelingen
ID

16752

Beschrijving

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

Trefwoorden

Versies (1)
  1. 03-08-16 03-08-16 -
Geüploaded op

3 augustus 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Eligibility Chronic Hepatitis C NCT00160251

    Engels

    Eligibility Chronic Hepatitis C NCT00160251

    1 Formulieren  
    Criteria
    Beschrijving

    Criteria

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

    chronic hepatitis c (chc), genotype 1

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C4049392 (Chronic hepatitis C genotype 1)
    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)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0162643 (treatment failure)
    UMLS CUI [1,2]
    C0919875 (Therapy non-responder)
    UMLS CUI [1,3]
    C1875630 (PEGINTERFERON/RIBAVIRIN)
    no evidence of cirrhosis on liver biopsy.
    Beschrijving

    no evidence of cirrhosis on liver biopsy.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023890 (Liver Cirrhosis)
    SNOMED
    19943007
    UMLS CUI [1,2]
    C0193388 (Biopsy of liver (procedure))
    SNOMED
    86259008
    results of physical examination and laboratory tests within specified ranges.
    Beschrijving

    results of physical examination and laboratory tests within specified ranges

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0459422 (Normal result)
    SNOMED
    280413001
    UMLS CUI [2,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [2,2]
    C0459422 (Normal result)
    SNOMED
    280413001
    abstinence from use of abused substances.
    Beschrijving

    abstinence from use of abused substances

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3843422 (Abstinence)
    LOINC
    LA14550-0
    UMLS CUI [1,2]
    C0687130 (Substance of abuse)
    key exclusion criteria:
    Beschrijving

    exclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    women who are pregnant or nursing a child.
    Beschrijving

    pregnant or breastfeeding

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    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).
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023890 (Liver Cirrhosis)
    SNOMED
    19943007
    UMLS CUI [2,1]
    C0275524 (Coinfection)
    SNOMED
    4559000
    LOINC
    LP281361-8
    UMLS CUI [2,2]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [3,1]
    C0275524 (Coinfection)
    SNOMED
    4559000
    LOINC
    LP281361-8
    UMLS CUI [3,2]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [4]
    C0085756 (African American)
    SNOMED
    15086000
    LOINC
    LA10610-6
    previous treatment with any hepatitis c virus (hcv) polymerase or protease inhibitor.
    Beschrijving

    hepatitis c virus (hcv) polymerase or protease inhibitor

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    UMLS CUI [1,2]
    C2746051 (DNA Polymerase Inhibitors)
    UMLS CUI [2,1]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    UMLS CUI [2,2]
    C0033607 (Protease Inhibitors)
    SNOMED
    412127001
    patients who relapsed following response to previous treatment.
    Beschrijving

    relapse

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    evidence of advanced liver disease, or liver disease from a cause other than chc.
    Beschrijving

    advanced liver disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0860197 (Advanced chronic liver disease)
    UMLS CUI [2]
    C0009488 (Comorbidity)
    pre-existing psychiatric condition.
    Beschrijving

    psychiatric condition

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    Terug naar het begin van de pagina

    Similar models

    Eligibility Chronic Hepatitis C NCT00160251

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial