ID

29684

Description

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

Keywords

Versions (1)
  1. 4/11/18 4/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 11, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00423891

English

Eligibility Hepatitis B, Chronic NCT00423891

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
2-18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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).
Description

Lamivudine naive | Lamivudine | Nucleosides | Nucleotides

Data type

boolean

Alias
UMLS CUI [1,1]
C0209738
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C0209738
UMLS CUI [3]
C0028621
UMLS CUI [4]
C0028630
hbv deoxyribonucleic acid (dna) ≥ 100000 copies/ml; ≥ 10000 copies for nucleoside/nucleotide experienced (group c)
Description

Hepatitis B DNA Measurement | Nucleosides | Nucleotides

Data type

boolean

Alias
UMLS CUI [1]
C3641250
UMLS CUI [2]
C0028621
UMLS CUI [3]
C0028630
detectable hepatitis b surface antigen (hbsag) for 24 weeks prior to screening
Description

Hepatitis B Surface Antigens Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C3830527
hepatitis b e antigen (hbeag) positive
Description

Hepatitis B e antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0392390
compensated liver and renal function
Description

Liver function Compensated | Renal function Compensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205432
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205432
elevated alanine aminotransferase (alt) at screening and during the 24 weeks prior to screening (for groups a and b)
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis d virus (hdv)
Description

HIV coinfection | HCV coinfection | HDV Coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
children who were breastfed while their mother received lamivudine, or children whose mothers received lamivudine during pregnancy
Description

Children | Mother Lamivudine Breast Feeding | Mother Lamivudine Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0026591
UMLS CUI [2,2]
C0209738
UMLS CUI [2,3]
C0006147
UMLS CUI [3,1]
C0026591
UMLS CUI [3,2]
C0209738
UMLS CUI [3,3]
C0032961
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Similar models

Eligibility Hepatitis B, Chronic NCT00423891

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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