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ID
29684
Beschrijving
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00423891
Link
https://clinicaltrials.gov/show/NCT00423891
Trefwoorden
Versies (1)
- 11-04-18 11-04-18 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
11 april 2018
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00423891
Eligibility Hepatitis B, Chronic NCT00423891
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B, Chronic NCT00423891
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Age
Item
2-18 years of age
boolean
C0001779 (UMLS CUI [1])
Lamivudine naive | Lamivudine | Nucleosides | Nucleotides
Item
group a: lamivudine naive (<1 week of lamivudine) and not within 24 weeks of screening; group b: lamivudine experienced (> 12 weeks of lamivudine); group c: nucleoside/nucleotide experienced (> 12 weeks of nucleoside/tide therapy) added as a country-specific protocol amendment (not all sites had group c).
boolean
C0209738 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0209738 (UMLS CUI [2])
C0028621 (UMLS CUI [3])
C0028630 (UMLS CUI [4])
C0919936 (UMLS CUI [1,2])
C0209738 (UMLS CUI [2])
C0028621 (UMLS CUI [3])
C0028630 (UMLS CUI [4])
Hepatitis B DNA Measurement | Nucleosides | Nucleotides
Item
hbv deoxyribonucleic acid (dna) ≥ 100000 copies/ml; ≥ 10000 copies for nucleoside/nucleotide experienced (group c)
boolean
C3641250 (UMLS CUI [1])
C0028621 (UMLS CUI [2])
C0028630 (UMLS CUI [3])
C0028621 (UMLS CUI [2])
C0028630 (UMLS CUI [3])
Hepatitis B Surface Antigens Detectable
Item
detectable hepatitis b surface antigen (hbsag) for 24 weeks prior to screening
boolean
C0019168 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,2])
Hepatitis B e antigen positive
Item
hepatitis b e antigen (hbeag) positive
boolean
C0392390 (UMLS CUI [1])
Liver function Compensated | Renal function Compensated
Item
compensated liver and renal function
boolean
C0232741 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0205432 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
Alanine aminotransferase increased
Item
elevated alanine aminotransferase (alt) at screening and during the 24 weeks prior to screening (for groups a and b)
boolean
C0151905 (UMLS CUI [1])
HIV coinfection | HCV coinfection | HDV Coinfection
Item
coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis d virus (hdv)
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Children | Mother Lamivudine Breast Feeding | Mother Lamivudine Pregnancy
Item
children who were breastfed while their mother received lamivudine, or children whose mothers received lamivudine during pregnancy
boolean
C0008059 (UMLS CUI [1])
C0026591 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C0006147 (UMLS CUI [2,3])
C0026591 (UMLS CUI [3,1])
C0209738 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0026591 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C0006147 (UMLS CUI [2,3])
C0026591 (UMLS CUI [3,1])
C0209738 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])