0 Beoordelingen
ID

42777

Beschrijving

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

Trefwoorden

Versies (2)
  1. 03-08-16 03-08-16 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Eligibility Chronic Hepatitis B NCT00895596

    Engels

    Eligibility Chronic Hepatitis B NCT00895596

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    compensated chronic hepatitis b patient
    Beschrijving

    compensated chronic hepatitis b

    Datatype

    boolean

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

    serum hbsag

    Datatype

    boolean

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

    hbeag with compensated liver disease

    Datatype

    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)
    Beschrijving

    ymdd mutants

    Datatype

    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)
    Beschrijving

    hbv dna

    Datatype

    boolean

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

    alt

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

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

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

    Datatype

    boolean

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

    pregnancy or breastfeeding

    Datatype

    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
    Beschrijving

    treatment with nucleoside analogue or any other treatment for hbv

    Datatype

    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.
    Beschrijving

    immunomodulatory agent or corticosteroids

    Datatype

    boolean

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

    decompensated liver disease

    Datatype

    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.
    Beschrijving

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

    Datatype

    boolean

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

    anti-hbs

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201478
    Terug naar het begin van de pagina

    Similar models

    Eligibility Chronic Hepatitis B NCT00895596

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial