ID

29682

Description

Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00410072

Link

https://clinicaltrials.gov/show/NCT00410072

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 NCT00410072

English

Eligibility Hepatitis B, Chronic NCT00410072

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b virus (hbv) infection (hepatitis b e antigen [hbeag]-positive or negative) disease
Description

Hepatitis B, Chronic | Hepatitis B e antigen positive | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0392390
UMLS CUI [3]
C0948827
nucleoside- and nucleotide-naive
Description

Nucleosides naive | Nucleotides naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0028621
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0028630
UMLS CUI [2,2]
C0919936
males or females ≥16 years of age (or minimum age of consent in a given country)
Description

Age | Age Minimum Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1524031
UMLS CUI [2,3]
C0021430
compensated liver function
Description

Liver function Compensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205432
hbv dna >1.72*10*5*iu/ml (approximately 10*6*copies/ml) for hbeag-positive participants
Description

Hepatitis B DNA Measurement | Hepatitis B e antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C3641250
UMLS CUI [2]
C0392390
hbv dna >1.72*10*4*iu/ml (approximately 10*5*copies/ml) for hbe-ag-negative participants
Description

Hepatitis B DNA Measurement | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C3641250
UMLS CUI [2]
C0948827
alanine aminotransferase level ≥*upper limit of normal (uln) and ≤10*uln
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of decompensated cirrhosis
Description

Decompensated cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C1619727
coinfection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus
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
laboratory values out of protocol-specified range
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Hepatitis B, Chronic NCT00410072

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
chronic hepatitis b virus (hbv) infection (hepatitis b e antigen [hbeag]-positive or negative) disease
boolean
C0524909 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
C0948827 (UMLS CUI [3])
Nucleosides naive | Nucleotides naive
Item
nucleoside- and nucleotide-naive
boolean
C0028621 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0028630 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
Age | Age Minimum Consent
Item
males or females ≥16 years of age (or minimum age of consent in a given country)
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Liver function Compensated
Item
compensated liver function
boolean
C0232741 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Hepatitis B DNA Measurement | Hepatitis B e antigen positive
Item
hbv dna >1.72*10*5*iu/ml (approximately 10*6*copies/ml) for hbeag-positive participants
boolean
C3641250 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Hepatitis B DNA Measurement | Hepatitis B e antigen negative
Item
hbv dna >1.72*10*4*iu/ml (approximately 10*5*copies/ml) for hbe-ag-negative participants
boolean
C3641250 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Alanine aminotransferase increased
Item
alanine aminotransferase level ≥*upper limit of normal (uln) and ≤10*uln
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis
Item
evidence of decompensated cirrhosis
boolean
C1619727 (UMLS CUI [1])
HIV coinfection | HCV coinfection | HDV Coinfection
Item
coinfection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Laboratory test result abnormal
Item
laboratory values out of protocol-specified range
boolean
C0438215 (UMLS CUI [1])
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