0 Ratings
ID

42777

Description

Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00895596

Link

https://clinicaltrials.gov/show/NCT00895596

Keywords

Versions (2)
  1. 8/3/16 8/3/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Chronic Hepatitis B NCT00895596

    English

    Eligibility Chronic Hepatitis B NCT00895596

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    compensated chronic hepatitis b patient
    Description

    compensated chronic hepatitis b

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0524909
    UMLS CUI [1,2]
    C0205432
    presence of serum hbsag for more than 6 months.
    Description

    serum hbsag

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019168
    presence of hbeag for more than 1 month with compensated liver disease
    Description

    hbeag with compensated liver disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019167
    UMLS CUI [2,1]
    C0023895
    UMLS CUI [2,2]
    C0205432
    confirmation of ymdd mutants (m552v, m552i and its related double mutant at l528m) by genotyping of the ymdd motif using line probe assay (inno-lipa hbv dr assay)
    Description

    ymdd mutants

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1717884
    screening hbv dna value higher than or equal to 1,000,000 copies/ml (measured by the cobas amplicor hbv monitor™ assay)
    Description

    hbv dna

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3641250
    screening alt value between 1.5 and 10 x uln
    Description

    alt

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    co-infection with hepatitis c or d virus (hcv or hdv) or hiv
    Description

    co-infection with hepatitis c or d virus (hcv or hdv) or hiv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0275524
    UMLS CUI [2]
    C0220847
    UMLS CUI [3]
    C0011220
    UMLS CUI [4]
    C0019682
    pregnancy or breast-feeding
    Description

    pregnancy or breastfeeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    previous treatment with nucleoside analogue or any other treatment for hbv except for lamivudine within 6 months prior to study entry
    Description

    treatment with nucleoside analogue or any other treatment for hbv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1579410
    UMLS CUI [2,1]
    C0019163
    UMLS CUI [2,2]
    C0013227
    treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
    Description

    immunomodulatory agent or corticosteroids

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005525
    UMLS CUI [2]
    C0001617
    de-compensated liver disease
    Description

    decompensated liver disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4075847
    screening alpha-fetoprotein (afp) value > 20 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc.
    Description

    screening alpha-fetoprotein (afp), ultrasonography, indicative of hcc

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201539
    UMLS CUI [2]
    C0041618
    UMLS CUI [3]
    C2239176
    presence of anti-hbs at screening
    Description

    anti-hbs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201478
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    Similar models

    Eligibility Chronic Hepatitis B NCT00895596

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    compensated chronic hepatitis b
    Item
    compensated chronic hepatitis b patient
    boolean
    C0524909 (UMLS CUI [1,1])
    C0205432 (UMLS CUI [1,2])
    serum hbsag
    Item
    presence of serum hbsag for more than 6 months.
    boolean
    C0019168 (UMLS CUI [1])
    hbeag with compensated liver disease
    Item
    presence of hbeag for more than 1 month with compensated liver disease
    boolean
    C0019167 (UMLS CUI [1])
    C0023895 (UMLS CUI [2,1])
    C0205432 (UMLS CUI [2,2])
    ymdd mutants
    Item
    confirmation of ymdd mutants (m552v, m552i and its related double mutant at l528m) by genotyping of the ymdd motif using line probe assay (inno-lipa hbv dr assay)
    boolean
    C1717884 (UMLS CUI [1])
    hbv dna
    Item
    screening hbv dna value higher than or equal to 1,000,000 copies/ml (measured by the cobas amplicor hbv monitor™ assay)
    boolean
    C3641250 (UMLS CUI [1])
    alt
    Item
    screening alt value between 1.5 and 10 x uln
    boolean
    C0201836 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    co-infection with hepatitis c or d virus (hcv or hdv) or hiv
    Item
    co-infection with hepatitis c or d virus (hcv or hdv) or hiv
    boolean
    C0275524 (UMLS CUI [1])
    C0220847 (UMLS CUI [2])
    C0011220 (UMLS CUI [3])
    C0019682 (UMLS CUI [4])
    pregnancy or breastfeeding
    Item
    pregnancy or breast-feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    treatment with nucleoside analogue or any other treatment for hbv
    Item
    previous treatment with nucleoside analogue or any other treatment for hbv except for lamivudine within 6 months prior to study entry
    boolean
    C1579410 (UMLS CUI [1])
    C0019163 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    immunomodulatory agent or corticosteroids
    Item
    treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
    boolean
    C0005525 (UMLS CUI [1])
    C0001617 (UMLS CUI [2])
    decompensated liver disease
    Item
    de-compensated liver disease
    boolean
    C4075847 (UMLS CUI [1])
    screening alpha-fetoprotein (afp), ultrasonography, indicative of hcc
    Item
    screening alpha-fetoprotein (afp) value > 20 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc.
    boolean
    C0201539 (UMLS CUI [1])
    C0041618 (UMLS CUI [2])
    C2239176 (UMLS CUI [3])
    anti-hbs
    Item
    presence of anti-hbs at screening
    boolean
    C0201478 (UMLS CUI [1])
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