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ID

44001

Beschrijving

Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis; ODM derived from: https://clinicaltrials.gov/show/NCT00029107

Link

https://clinicaltrials.gov/show/NCT00029107

Trefwoorden

Versies (2)
  1. 08-07-16 08-07-16 -
  2. 20-09-21 20-09-21 -
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20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Hepatitis C NCT00029107

    Engels

    Eligibility Hepatitis C NCT00029107

    1 Formulieren  
    Criteria
    Beschrijving

    Criteria

    diagnosis of hcv-cv: must have all of the following
    Beschrijving

    diagnosis of hcv-cv

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019196
    hcv infection documented by serology and/or plasma hcv rna.
    Beschrijving

    hcv rna- or seropositive

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1269695
    UMLS CUI [2]
    C0855842
    one or more organ system with objective evidence of active vasculitis such as:
    Beschrijving

    active vasculitis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0042384
    palpable purpura
    Beschrijving

    palpable purpura

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151190
    glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria);
    Beschrijving

    glomerulonephritis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0017658
    acute peripheral neuropathy.
    Beschrijving

    acute peripheral neuropathy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0031117
    detectable cryoglobulins and/or rf.
    Beschrijving

    detectable cryoglobulins or rheumatoid factors

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0392385
    UMLS CUI [2]
    C0151379
    failure of treatment with ifn-alpha and ribavirin to control manifestations of hcv-cv or intolerance to ifn-alpha/ribavirin regimen.
    Beschrijving

    cytostatic treatment failure

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0162643
    UMLS CUI [1,2]
    C0002199
    UMLS CUI [2,1]
    C0162643
    UMLS CUI [2,2]
    C0035525
    patients must have a personal physician responsible for the care of their hcv.
    Beschrijving

    personal physician

    Datatype

    boolean

    ages of 18 and 75 years
    Beschrijving

    age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    willingness to use effective contraception during and for 12 months following rituximab treatment. effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
    Beschrijving

    contraceptive methods

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    recent (within 4 weeks) initiation of or increase in immunosuppressive therapy.
    Beschrijving

    immunosuppressive therapy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021079
    active systemic infection (other than hepatitis c).
    Beschrijving

    active systemic infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    pregnancy or breast feeding.
    Beschrijving

    pregnancy or breast feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    prior treatment with rituximab.
    Beschrijving

    prior treatment with rituximab

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0393022
    known allergy to murine proteins.
    Beschrijving

    allergy to murine proteins

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1699668
    significant renal insufficiency (creatinine clearance less than 30 ml/min).
    Beschrijving

    renal insufficiency

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    presence of life-threatening hcv-cv; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), cns vasculitis, cardiac disease due to active vasculitis, or gi vasculitis (defined by ischemic bowel, perforation, or infarction).
    Beschrijving

    life-threatening hcv-cv

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0221239
    UMLS CUI [2]
    C0042384
    UMLS CUI [3]
    C0856069
    significant hepatic insufficiency as manifested by child-pugh classification of b or c.
    Beschrijving

    hepatic insufficiency

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1306571
    UMLS CUI [1,2]
    C4050412
    history of variceal bleeding, encephalopathy.
    Beschrijving

    variceal bleeding or encephalopathy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1739112
    UMLS CUI [2]
    C0085584
    history of liver transplantation.
    Beschrijving

    history of liver transplantation.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0023911
    co-infection with either hbv or hiv.
    Beschrijving

    co-infection with either hbv or hiv

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2242656
    UMLS CUI [2]
    C4062778
    any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events.
    Beschrijving

    any condition compromising study protocol compliance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    Terug naar het begin van de pagina

    Similar models

    Eligibility Hepatitis C NCT00029107

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    diagnosis of hcv-cv
    Item
    diagnosis of hcv-cv: must have all of the following
    boolean
    C0019196 (UMLS CUI [1])
    hcv rna- or seropositive
    Item
    hcv infection documented by serology and/or plasma hcv rna.
    boolean
    C1269695 (UMLS CUI [1])
    C0855842 (UMLS CUI [2])
    active vasculitis
    Item
    one or more organ system with objective evidence of active vasculitis such as:
    boolean
    C0042384 (UMLS CUI [1])
    palpable purpura
    Item
    palpable purpura
    boolean
    C0151190 (UMLS CUI [1])
    glomerulonephritis
    Item
    glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria);
    boolean
    C0017658 (UMLS CUI [1])
    acute peripheral neuropathy
    Item
    acute peripheral neuropathy.
    boolean
    C0031117 (UMLS CUI [1])
    detectable cryoglobulins or rheumatoid factors
    Item
    detectable cryoglobulins and/or rf.
    boolean
    C0392385 (UMLS CUI [1])
    C0151379 (UMLS CUI [2])
    cytostatic treatment failure
    Item
    failure of treatment with ifn-alpha and ribavirin to control manifestations of hcv-cv or intolerance to ifn-alpha/ribavirin regimen.
    boolean
    C0162643 (UMLS CUI [1,1])
    C0002199 (UMLS CUI [1,2])
    C0162643 (UMLS CUI [2,1])
    C0035525 (UMLS CUI [2,2])
    personal physician
    Item
    patients must have a personal physician responsible for the care of their hcv.
    boolean
    age
    Item
    ages of 18 and 75 years
    boolean
    C0001779 (UMLS CUI [1])
    contraceptive methods
    Item
    willingness to use effective contraception during and for 12 months following rituximab treatment. effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
    boolean
    C0700589 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    immunosuppressive therapy
    Item
    recent (within 4 weeks) initiation of or increase in immunosuppressive therapy.
    boolean
    C0021079 (UMLS CUI [1])
    active systemic infection
    Item
    active systemic infection (other than hepatitis c).
    boolean
    C0009450 (UMLS CUI [1])
    pregnancy or breast feeding
    Item
    pregnancy or breast feeding.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    prior treatment with rituximab
    Item
    prior treatment with rituximab.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0393022 (UMLS CUI [1,2])
    allergy to murine proteins
    Item
    known allergy to murine proteins.
    boolean
    C0020517 (UMLS CUI [1,1])
    C1699668 (UMLS CUI [1,2])
    renal insufficiency
    Item
    significant renal insufficiency (creatinine clearance less than 30 ml/min).
    boolean
    C1565489 (UMLS CUI [1])
    life-threatening hcv-cv
    Item
    presence of life-threatening hcv-cv; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), cns vasculitis, cardiac disease due to active vasculitis, or gi vasculitis (defined by ischemic bowel, perforation, or infarction).
    boolean
    C0221239 (UMLS CUI [1])
    C0042384 (UMLS CUI [2])
    C0856069 (UMLS CUI [3])
    hepatic insufficiency
    Item
    significant hepatic insufficiency as manifested by child-pugh classification of b or c.
    boolean
    C1306571 (UMLS CUI [1,1])
    C4050412 (UMLS CUI [1,2])
    variceal bleeding or encephalopathy
    Item
    history of variceal bleeding, encephalopathy.
    boolean
    C1739112 (UMLS CUI [1])
    C0085584 (UMLS CUI [2])
    history of liver transplantation.
    Item
    history of liver transplantation.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0023911 (UMLS CUI [1,2])
    co-infection with either hbv or hiv
    Item
    co-infection with either hbv or hiv.
    boolean
    C2242656 (UMLS CUI [1])
    C4062778 (UMLS CUI [2])
    any condition compromising study protocol compliance
    Item
    any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    Terug naar het begin van de pagina 

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