0 Avaliações
ID

44537

Descrição

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002); ODM derived from: https://clinicaltrials.gov/show/NCT01554189

Link

https://clinicaltrials.gov/show/NCT01554189

Palavras-chave

Versões (2)
  1. 21/05/2020 21/05/2020 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Hepatitis C, Chronic NCT01554189

    Inglês

    Eligibility Hepatitis C, Chronic NCT01554189

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    body mass index (bmi) of 18 to ≤37 kg/m^2
    Descrição

    Body mass index

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    diagnosis of chronic hcv infection
    Descrição

    Hepatitis C, Chronic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0524910
    must be infected with hcv gt1a, gt1b, or gt3
    Descrição

    Patient Infected Hepatitis C virus genotype

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0439663
    UMLS CUI [1,3]
    C1533728
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    co-infection with gt1 and gt3 hcv
    Descrição

    HCV coinfection Genotype

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1698259
    UMLS CUI [1,2]
    C1533728
    history of stroke, chronic seizures, or major neurological disorder
    Descrição

    Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    UMLS CUI [2,1]
    C0036572
    UMLS CUI [2,2]
    C0205191
    UMLS CUI [3,1]
    C0027765
    UMLS CUI [3,2]
    C0205164
    history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
    Descrição

    Endocrine System Diseases | Gastrointestinal Diseases | Exception Hepatitis C | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0014130
    UMLS CUI [2]
    C0017178
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0019196
    UMLS CUI [4]
    C0007222
    UMLS CUI [5]
    C0018939
    UMLS CUI [6]
    C0021053
    UMLS CUI [7]
    C0022658
    UMLS CUI [8]
    C0035204
    UMLS CUI [9]
    C0080276
    history of neoplastic disease
    Descrição

    Neoplastic disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1882062
    positive hepatitis b surface antigen
    Descrição

    Hepatitis B surface antigen positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0149709
    history of human immunodeficiency virus (hiv) infection or positive hiv serology
    Descrição

    HIV Infection | HIV Seropositivity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0019699
    major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior
    Descrição

    Major surgery | Blood Donation Amount | Blood Loss Amount | Study Subject Participation Status | Research study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2,1]
    C0005794
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [3,1]
    C3163616
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [4]
    C2348568
    UMLS CUI [5]
    C0681814
    history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
    Descrição

    Multiple allergies | Severe allergy | Latex allergy | Anaphylaxis Prescription Drugs | Anaphylaxis Non-Prescription Drugs | Anaphylaxis Food | Intolerance to Prescription Drugs | Intolerance to Non-Prescription Drugs | Intolerance to Food

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0740281
    UMLS CUI [2]
    C2945656
    UMLS CUI [3]
    C0577628
    UMLS CUI [4,1]
    C0002792
    UMLS CUI [4,2]
    C0304227
    UMLS CUI [5,1]
    C0002792
    UMLS CUI [5,2]
    C0013231
    UMLS CUI [6,1]
    C0002792
    UMLS CUI [6,2]
    C0016452
    UMLS CUI [7,1]
    C1744706
    UMLS CUI [7,2]
    C0304227
    UMLS CUI [8,1]
    C1744706
    UMLS CUI [8,2]
    C0013231
    UMLS CUI [9,1]
    C1744706
    UMLS CUI [9,2]
    C0016452
    current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
    Descrição

    Illicit medication use | Substance Use Disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0281875
    UMLS CUI [2]
    C0038586
    evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, autoimmune hepatitis
    Descrição

    Hepatitis, Chronic | Etiology Absent Hepatitis C virus | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Autoimmune hepatitis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019189
    UMLS CUI [2,1]
    C0015127
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [2,3]
    C0220847
    UMLS CUI [3]
    C0042721
    UMLS CUI [4]
    C3241937
    UMLS CUI [5]
    C1262760
    UMLS CUI [6]
    C4721555
    previous treatments(s) with nonstructural 5a (ns5a) protein inhibitors
    Descrição

    Hepatitis C virus NS5A inhibitor

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4041197
    treatment with protease inhibitor(s) <30 days prior to study enrollment
    Descrição

    Protease Inhibitors

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0033607
    previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of mk-8325 in the study
    Descrição

    Exposure to Interferon-alpha | Exposure to Ribavirin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0002199
    UMLS CUI [2,1]
    C0332157
    UMLS CUI [2,2]
    C0035525
    clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
    Descrição

    Liver disease Advanced | Decompensated Liver Disease | Bridging fibrosis | Fibrosis METAVIR Score

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [2]
    C0745744
    UMLS CUI [3]
    C0334160
    UMLS CUI [4,1]
    C0016059
    UMLS CUI [4,2]
    C3897040
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    Similar models

    Eligibility Hepatitis C, Chronic NCT01554189

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Body mass index
    Item
    body mass index (bmi) of 18 to ≤37 kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    Hepatitis C, Chronic
    Item
    diagnosis of chronic hcv infection
    boolean
    C0524910 (UMLS CUI [1])
    Patient Infected Hepatitis C virus genotype
    Item
    must be infected with hcv gt1a, gt1b, or gt3
    boolean
    C0030705 (UMLS CUI [1,1])
    C0439663 (UMLS CUI [1,2])
    C1533728 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    HCV coinfection Genotype
    Item
    co-infection with gt1 and gt3 hcv
    boolean
    C1698259 (UMLS CUI [1,1])
    C1533728 (UMLS CUI [1,2])
    Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
    Item
    history of stroke, chronic seizures, or major neurological disorder
    boolean
    C0038454 (UMLS CUI [1])
    C0036572 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    C0027765 (UMLS CUI [3,1])
    C0205164 (UMLS CUI [3,2])
    Endocrine System Diseases | Gastrointestinal Diseases | Exception Hepatitis C | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system
    Item
    history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
    boolean
    C0014130 (UMLS CUI [1])
    C0017178 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0019196 (UMLS CUI [3,2])
    C0007222 (UMLS CUI [4])
    C0018939 (UMLS CUI [5])
    C0021053 (UMLS CUI [6])
    C0022658 (UMLS CUI [7])
    C0035204 (UMLS CUI [8])
    C0080276 (UMLS CUI [9])
    Neoplastic disease
    Item
    history of neoplastic disease
    boolean
    C1882062 (UMLS CUI [1])
    Hepatitis B surface antigen positive
    Item
    positive hepatitis b surface antigen
    boolean
    C0149709 (UMLS CUI [1])
    HIV Infection | HIV Seropositivity
    Item
    history of human immunodeficiency virus (hiv) infection or positive hiv serology
    boolean
    C0019693 (UMLS CUI [1])
    C0019699 (UMLS CUI [2])
    Major surgery | Blood Donation Amount | Blood Loss Amount | Study Subject Participation Status | Research study
    Item
    major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior
    boolean
    C0679637 (UMLS CUI [1])
    C0005794 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C3163616 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C2348568 (UMLS CUI [4])
    C0681814 (UMLS CUI [5])
    Multiple allergies | Severe allergy | Latex allergy | Anaphylaxis Prescription Drugs | Anaphylaxis Non-Prescription Drugs | Anaphylaxis Food | Intolerance to Prescription Drugs | Intolerance to Non-Prescription Drugs | Intolerance to Food
    Item
    history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
    boolean
    C0740281 (UMLS CUI [1])
    C2945656 (UMLS CUI [2])
    C0577628 (UMLS CUI [3])
    C0002792 (UMLS CUI [4,1])
    C0304227 (UMLS CUI [4,2])
    C0002792 (UMLS CUI [5,1])
    C0013231 (UMLS CUI [5,2])
    C0002792 (UMLS CUI [6,1])
    C0016452 (UMLS CUI [6,2])
    C1744706 (UMLS CUI [7,1])
    C0304227 (UMLS CUI [7,2])
    C1744706 (UMLS CUI [8,1])
    C0013231 (UMLS CUI [8,2])
    C1744706 (UMLS CUI [9,1])
    C0016452 (UMLS CUI [9,2])
    Illicit medication use | Substance Use Disorders
    Item
    current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
    boolean
    C0281875 (UMLS CUI [1])
    C0038586 (UMLS CUI [2])
    Hepatitis, Chronic | Etiology Absent Hepatitis C virus | Viral hepatitis | Nonalcoholic Steatohepatitis | Hepatitis, Drug-Induced | Autoimmune hepatitis
    Item
    evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, autoimmune hepatitis
    boolean
    C0019189 (UMLS CUI [1])
    C0015127 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0220847 (UMLS CUI [2,3])
    C0042721 (UMLS CUI [3])
    C3241937 (UMLS CUI [4])
    C1262760 (UMLS CUI [5])
    C4721555 (UMLS CUI [6])
    Hepatitis C virus NS5A inhibitor
    Item
    previous treatments(s) with nonstructural 5a (ns5a) protein inhibitors
    boolean
    C4041197 (UMLS CUI [1])
    Protease Inhibitors
    Item
    treatment with protease inhibitor(s) <30 days prior to study enrollment
    boolean
    C0033607 (UMLS CUI [1])
    Exposure to Interferon-alpha | Exposure to Ribavirin
    Item
    previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of mk-8325 in the study
    boolean
    C0332157 (UMLS CUI [1,1])
    C0002199 (UMLS CUI [1,2])
    C0332157 (UMLS CUI [2,1])
    C0035525 (UMLS CUI [2,2])
    Liver disease Advanced | Decompensated Liver Disease | Bridging fibrosis | Fibrosis METAVIR Score
    Item
    clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
    boolean
    C0023895 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C0745744 (UMLS CUI [2])
    C0334160 (UMLS CUI [3])
    C0016059 (UMLS CUI [4,1])
    C3897040 (UMLS CUI [4,2])
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