0 Ratings
ID

20909

Description

Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00426712

Link

https://clinicaltrials.gov/show/NCT00426712

Keywords

Versions (1)
  1. 3/27/17 3/27/17 -
Uploaded on

March 27, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatitis B NCT00426712

    English

    Eligibility Hepatitis B NCT00426712

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    willing and able to give written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    progressive loss of kidney function with more advanced stage 3 (gfr at least 45 ml/min) or stage 4 chronic kidney disease by national kidney foundation classification, and are expected to eventually go on hemodialysis
    Description

    Renal function Loss Progressive | Chronic kidney disease Chronic kidney disease NKF classification | Hemodialysis Expected

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C1517945
    UMLS CUI [1,3]
    C0205329
    UMLS CUI [2,1]
    C1561643
    UMLS CUI [2,2]
    C2074730
    UMLS CUI [3,1]
    C0019004
    UMLS CUI [3,2]
    C1517001
    body mass index of 31 or less
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    received previous vaccination with any hbv vaccine (1 or more doses)
    Description

    Vaccination Hepatitis B Vaccine Dose Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2240392
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C1265611
    any history of hbv infection
    Description

    Hepatitis B

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    pregnant or breast-feeding, or planning a pregnancy during the study
    Description

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    has autoimmune disease
    Description

    Autoimmune Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    diagnosis of chronic kidney failure due to autoimmune disease
    Description

    Chronic Kidney Failure Due to Autoimmune Disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022661
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0004364
    receiving hemodialysis treatment at the time of enrollment
    Description

    Hemodialysis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019004
    received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
    Description

    Blood product | Antibodies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0456388
    UMLS CUI [2]
    C3495458
    ever received an injection with dna plasmids or oligonucleotides
    Description

    Plasmid DNA Injection | Oligonucleotides Injection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032136
    UMLS CUI [1,2]
    C1828121
    UMLS CUI [2,1]
    C0028953
    UMLS CUI [2,2]
    C1828121
    received erythropoietin within 7 days prior to the first study injection
    Description

    Erythropoietin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0014822
    received vaccination with any vaccines during the 4 weeks prior to study entry
    Description

    Vaccination Vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C0042210
    received any other investigational medicinal agent during the 4 weeks prior to study entry
    Description

    Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
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    Similar models

    Eligibility Hepatitis B NCT00426712

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    willing and able to give written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Renal function Loss Progressive | Chronic kidney disease Chronic kidney disease NKF classification | Hemodialysis Expected
    Item
    progressive loss of kidney function with more advanced stage 3 (gfr at least 45 ml/min) or stage 4 chronic kidney disease by national kidney foundation classification, and are expected to eventually go on hemodialysis
    boolean
    C0232804 (UMLS CUI [1,1])
    C1517945 (UMLS CUI [1,2])
    C0205329 (UMLS CUI [1,3])
    C1561643 (UMLS CUI [2,1])
    C2074730 (UMLS CUI [2,2])
    C0019004 (UMLS CUI [3,1])
    C1517001 (UMLS CUI [3,2])
    Body mass index
    Item
    body mass index of 31 or less
    boolean
    C1305855 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Vaccination Hepatitis B Vaccine Dose Quantity
    Item
    received previous vaccination with any hbv vaccine (1 or more doses)
    boolean
    C0042196 (UMLS CUI [1,1])
    C2240392 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C1265611 (UMLS CUI [1,4])
    Hepatitis B
    Item
    any history of hbv infection
    boolean
    C0019163 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Pregnancy, Planned
    Item
    pregnant or breast-feeding, or planning a pregnancy during the study
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Autoimmune Disease
    Item
    has autoimmune disease
    boolean
    C0004364 (UMLS CUI [1])
    Chronic Kidney Failure Due to Autoimmune Disease
    Item
    diagnosis of chronic kidney failure due to autoimmune disease
    boolean
    C0022661 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0004364 (UMLS CUI [1,3])
    Hemodialysis
    Item
    receiving hemodialysis treatment at the time of enrollment
    boolean
    C0019004 (UMLS CUI [1])
    Blood product | Antibodies
    Item
    received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
    boolean
    C0456388 (UMLS CUI [1])
    C3495458 (UMLS CUI [2])
    Plasmid DNA Injection | Oligonucleotides Injection
    Item
    ever received an injection with dna plasmids or oligonucleotides
    boolean
    C0032136 (UMLS CUI [1,1])
    C1828121 (UMLS CUI [1,2])
    C0028953 (UMLS CUI [2,1])
    C1828121 (UMLS CUI [2,2])
    Erythropoietin
    Item
    received erythropoietin within 7 days prior to the first study injection
    boolean
    C0014822 (UMLS CUI [1])
    Vaccination Vaccine
    Item
    received vaccination with any vaccines during the 4 weeks prior to study entry
    boolean
    C0042196 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Investigational New Drugs
    Item
    received any other investigational medicinal agent during the 4 weeks prior to study entry
    boolean
    C0013230 (UMLS CUI [1])
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