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ID

44001

Description

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

Link

https://clinicaltrials.gov/show/NCT00029107

Keywords

Versions (2)
  1. 7/8/16 7/8/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatitis C NCT00029107

    English

    Eligibility Hepatitis C NCT00029107

    1 forms  
    Criteria
    Description

    Criteria

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

    diagnosis of hcv-cv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    hcv infection documented by serology and/or plasma hcv rna.
    Description

    hcv rna- or seropositive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1269695 (Hepatitis C antibody positive with elevated ALT)
    SNOMED
    370988000
    UMLS CUI [2]
    C0855842 (Hepatitis C RNA positive)
    one or more organ system with objective evidence of active vasculitis such as:
    Description

    active vasculitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042384 (Vasculitis)
    SNOMED
    31996006
    LOINC
    LA17783-4
    palpable purpura
    Description

    palpable purpura

    Data type

    boolean

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

    glomerulonephritis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017658 (Glomerulonephritis)
    SNOMED
    36171008
    acute peripheral neuropathy.
    Description

    acute peripheral neuropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031117 (Peripheral Neuropathy)
    detectable cryoglobulins and/or rf.
    Description

    detectable cryoglobulins or rheumatoid factors

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392385 (Cryoglobulins present)
    UMLS CUI [2]
    C0151379 (Rheumatoid factor positive (finding))
    SNOMED
    165839004
    failure of treatment with ifn-alpha and ribavirin to control manifestations of hcv-cv or intolerance to ifn-alpha/ribavirin regimen.
    Description

    cytostatic treatment failure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0162643 (treatment failure)
    UMLS CUI [1,2]
    C0002199 (Interferon-alpha)
    SNOMED
    45754009
    UMLS CUI [2,1]
    C0162643 (treatment failure)
    UMLS CUI [2,2]
    C0035525 (ribavirin)
    SNOMED
    35063004
    patients must have a personal physician responsible for the care of their hcv.
    Description

    personal physician

    Data type

    boolean

    ages of 18 and 75 years
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    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.
    Description

    contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    immunosuppressive therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021079 (Therapeutic immunosuppression)
    SNOMED
    86553008
    active systemic infection (other than hepatitis c).
    Description

    active systemic infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    pregnancy or breast feeding.
    Description

    pregnancy or breast feeding

    Data type

    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
    prior treatment with rituximab.
    Description

    prior treatment with rituximab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C0393022 (rituximab)
    SNOMED
    108809004
    known allergy to murine proteins.
    Description

    allergy to murine proteins

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C1699668 (murine protein)
    significant renal insufficiency (creatinine clearance less than 30 ml/min).
    Description

    renal insufficiency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489 (Renal Insufficiency)
    SNOMED
    236423003
    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).
    Description

    life-threatening hcv-cv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221239 (Rapidly progressive glomerulonephritis)
    SNOMED
    236392004
    UMLS CUI [2]
    C0042384 (Vasculitis)
    SNOMED
    31996006
    LOINC
    LA17783-4
    UMLS CUI [3]
    C0856069 (Vasculitis gastrointestinal)
    significant hepatic insufficiency as manifested by child-pugh classification of b or c.
    Description

    hepatic insufficiency

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1306571 (Hepatic Insufficiency)
    UMLS CUI [1,2]
    C4050412 (Child-Pugh Clinical Classification)
    SNOMED
    3191000175106
    history of variceal bleeding, encephalopathy.
    Description

    variceal bleeding or encephalopathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1739112 (Gastrooesophageal variceal haemorrhage prophylaxis)
    UMLS CUI [2]
    C0085584 (Encephalopathies)
    history of liver transplantation.
    Description

    history of liver transplantation.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0023911 (Transplantation of liver)
    SNOMED
    18027006
    co-infection with either hbv or hiv.
    Description

    co-infection with either hbv or hiv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2242656 (HBV coinfection)
    UMLS CUI [2]
    C4062778 (Human immunodeficiency virus (HIV) coinfection)
    any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events.
    Description

    any condition compromising study protocol compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
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    Similar models

    Eligibility Hepatitis C NCT00029107

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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