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ID

40913

Descrizione

Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514); ODM derived from: https://clinicaltrials.gov/show/NCT00910624

collegamento

https://clinicaltrials.gov/show/NCT00910624

Keywords

versioni (1)
  1. 03/06/20 03/06/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

3 giugno 2020

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Hepatitis C, Chronic NCT00910624

    Inglese

    Eligibility Hepatitis C, Chronic NCT00910624

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    participant must have been assigned to a peg/rbv control arm in a previous spri study of boc, must have completed treatment as per protocol, and have been compliant with all study treatment and scheduled procedures within the previous study.
    Descrizione

    Assignment Protocol Arm PEGINTERFERON/RIBAVIRIN | Treatment completed | Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1516050
    UMLS CUI [1,2]
    C1522541
    UMLS CUI [1,3]
    C1875630
    UMLS CUI [2]
    C0580352
    UMLS CUI [3]
    C0525058
    participant must have received at least 12 weeks of treatment with peg/rbv and must have discontinued treatment in the previous study due to the futility rule (as defined in the previous protocol), had virologic breakthrough, or relapse.
    Descrizione

    PEGINTERFERON/RIBAVIRIN Duration of treatment | Therapy Discontinued | Viral Breakthrough | Relapse

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1875630
    UMLS CUI [1,2]
    C0444921
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C1444662
    UMLS CUI [3]
    C4053869
    UMLS CUI [4]
    C0035020
    participant must have had detectable hcv-rna upon completion of the previous study.
    Descrizione

    Hepatitis C RNA Detectable

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0855840
    UMLS CUI [1,2]
    C3830527
    participant and participant partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs, or longer if dictated by local regulations.
    Descrizione

    Study Subject Contraceptive methods | Partner Contraceptive methods

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C0682323
    UMLS CUI [2,2]
    C0700589
    participant must be willing to give written informed consent.
    Descrizione

    Informed Consent Willing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0600109
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    all participant exclusion criteria from the spri clinical study in which the participant participated prior to qualifying for this study will apply in this study, except for the following:
    Descrizione

    Exclusion Criteria Clinical Trial Specified

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0205369
    treatment with rbv within 90 days and any interferon-alpha within 1 month of the enrollment is not exclusionary in p05514.
    Descrizione

    Exception Ribavirin | Exception Interferon-alpha

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847
    UMLS CUI [1,2]
    C0035525
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0002199
    participation in any other spri clinical trial within 30 days of enrollment in this study is not exclusionary.
    Descrizione

    Participation Clinical Trial Specified allowed

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0679823
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0205369
    UMLS CUI [1,4]
    C0683607
    use of growth factor at the entry of the study is allowed if it was prescribed in the previous study.
    Descrizione

    Growth Factor allowed

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0018284
    UMLS CUI [1,2]
    C0683607
    laboratory criteria of thyroid-stimulating hormone (tsh) do not apply. laboratory criteria of hemoglobin, neutrophils, and platelets do not apply, unless they met dose reduction/interruption/discontinuation criteria in the previous study.
    Descrizione

    Laboratory Criteria Excluded | TSH | Hemoglobin | Neutrophils | Platelets

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0243161
    UMLS CUI [1,3]
    C0332196
    UMLS CUI [2]
    C0040160
    UMLS CUI [3]
    C0019046
    UMLS CUI [4]
    C0027950
    UMLS CUI [5]
    C0005821
    participants who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded
    Descrizione

    Exception | Moderate depression | Stable status | Well controlled

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1705847
    UMLS CUI [2]
    C0588007
    UMLS CUI [3]
    C0205360
    UMLS CUI [4]
    C3853142
    participants who had the opportunity to receive boceprevir in the previous study.
    Descrizione

    boceprevir

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1738934
    participants requiring discontinuation, interruption, or dose reduction of rbv for more than 2 weeks in the previous study.
    Descrizione

    Requirement Ribavirin Discontinuation | Requirement Ribavirin Interruption | Requirement Ribavirin Dose Reduction

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C0035525
    UMLS CUI [1,3]
    C1444662
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C0035525
    UMLS CUI [2,3]
    C1512900
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C0035525
    UMLS CUI [3,3]
    C0178602
    UMLS CUI [3,4]
    C0392756
    participants requiring discontinuation, interruption, or dose reduction of peg to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study.
    Descrizione

    Requirement PEGINTERFERON Discontinuation | Requirement PEGINTERFERON Interruption | Requirement PEGINTERFERON Dose Reduction

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1514873
    UMLS CUI [1,2]
    C0982327
    UMLS CUI [1,3]
    C1444662
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C0982327
    UMLS CUI [2,3]
    C1512900
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C0982327
    UMLS CUI [3,3]
    C0178602
    UMLS CUI [3,4]
    C0392756
    participants who experienced a life-threatening sae considered at least possibly related to study drugs by the investigator or sponsor in the previous study.
    Descrizione

    Adverse event Severe Life Threatening

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C2826244
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    Similar models

    Eligibility Hepatitis C, Chronic NCT00910624

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Assignment Protocol Arm PEGINTERFERON/RIBAVIRIN | Treatment completed | Protocol Compliance
    Item
    participant must have been assigned to a peg/rbv control arm in a previous spri study of boc, must have completed treatment as per protocol, and have been compliant with all study treatment and scheduled procedures within the previous study.
    boolean
    C1516050 (UMLS CUI [1,1])
    C1522541 (UMLS CUI [1,2])
    C1875630 (UMLS CUI [1,3])
    C0580352 (UMLS CUI [2])
    C0525058 (UMLS CUI [3])
    PEGINTERFERON/RIBAVIRIN Duration of treatment | Therapy Discontinued | Viral Breakthrough | Relapse
    Item
    participant must have received at least 12 weeks of treatment with peg/rbv and must have discontinued treatment in the previous study due to the futility rule (as defined in the previous protocol), had virologic breakthrough, or relapse.
    boolean
    C1875630 (UMLS CUI [1,1])
    C0444921 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C1444662 (UMLS CUI [2,2])
    C4053869 (UMLS CUI [3])
    C0035020 (UMLS CUI [4])
    Hepatitis C RNA Detectable
    Item
    participant must have had detectable hcv-rna upon completion of the previous study.
    boolean
    C0855840 (UMLS CUI [1,1])
    C3830527 (UMLS CUI [1,2])
    Study Subject Contraceptive methods | Partner Contraceptive methods
    Item
    participant and participant partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs, or longer if dictated by local regulations.
    boolean
    C0681850 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0682323 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Informed Consent Willing
    Item
    participant must be willing to give written informed consent.
    boolean
    C0021430 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion Criteria Clinical Trial Specified
    Item
    all participant exclusion criteria from the spri clinical study in which the participant participated prior to qualifying for this study will apply in this study, except for the following:
    boolean
    C0680251 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0205369 (UMLS CUI [1,3])
    Exception Ribavirin | Exception Interferon-alpha
    Item
    treatment with rbv within 90 days and any interferon-alpha within 1 month of the enrollment is not exclusionary in p05514.
    boolean
    C1705847 (UMLS CUI [1,1])
    C0035525 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0002199 (UMLS CUI [2,2])
    Participation Clinical Trial Specified allowed
    Item
    participation in any other spri clinical trial within 30 days of enrollment in this study is not exclusionary.
    boolean
    C0679823 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0205369 (UMLS CUI [1,3])
    C0683607 (UMLS CUI [1,4])
    Growth Factor allowed
    Item
    use of growth factor at the entry of the study is allowed if it was prescribed in the previous study.
    boolean
    C0018284 (UMLS CUI [1,1])
    C0683607 (UMLS CUI [1,2])
    Laboratory Criteria Excluded | TSH | Hemoglobin | Neutrophils | Platelets
    Item
    laboratory criteria of thyroid-stimulating hormone (tsh) do not apply. laboratory criteria of hemoglobin, neutrophils, and platelets do not apply, unless they met dose reduction/interruption/discontinuation criteria in the previous study.
    boolean
    C0022877 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    C0332196 (UMLS CUI [1,3])
    C0040160 (UMLS CUI [2])
    C0019046 (UMLS CUI [3])
    C0027950 (UMLS CUI [4])
    C0005821 (UMLS CUI [5])
    Exception | Moderate depression | Stable status | Well controlled
    Item
    participants who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded
    boolean
    C1705847 (UMLS CUI [1])
    C0588007 (UMLS CUI [2])
    C0205360 (UMLS CUI [3])
    C3853142 (UMLS CUI [4])
    boceprevir
    Item
    participants who had the opportunity to receive boceprevir in the previous study.
    boolean
    C1738934 (UMLS CUI [1])
    Requirement Ribavirin Discontinuation | Requirement Ribavirin Interruption | Requirement Ribavirin Dose Reduction
    Item
    participants requiring discontinuation, interruption, or dose reduction of rbv for more than 2 weeks in the previous study.
    boolean
    C1514873 (UMLS CUI [1,1])
    C0035525 (UMLS CUI [1,2])
    C1444662 (UMLS CUI [1,3])
    C1514873 (UMLS CUI [2,1])
    C0035525 (UMLS CUI [2,2])
    C1512900 (UMLS CUI [2,3])
    C1514873 (UMLS CUI [3,1])
    C0035525 (UMLS CUI [3,2])
    C0178602 (UMLS CUI [3,3])
    C0392756 (UMLS CUI [3,4])
    Requirement PEGINTERFERON Discontinuation | Requirement PEGINTERFERON Interruption | Requirement PEGINTERFERON Dose Reduction
    Item
    participants requiring discontinuation, interruption, or dose reduction of peg to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study.
    boolean
    C1514873 (UMLS CUI [1,1])
    C0982327 (UMLS CUI [1,2])
    C1444662 (UMLS CUI [1,3])
    C1514873 (UMLS CUI [2,1])
    C0982327 (UMLS CUI [2,2])
    C1512900 (UMLS CUI [2,3])
    C1514873 (UMLS CUI [3,1])
    C0982327 (UMLS CUI [3,2])
    C0178602 (UMLS CUI [3,3])
    C0392756 (UMLS CUI [3,4])
    Adverse event Severe Life Threatening
    Item
    participants who experienced a life-threatening sae considered at least possibly related to study drugs by the investigator or sponsor in the previous study.
    boolean
    C0877248 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C2826244 (UMLS CUI [1,3])
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