Information:
Fel:
ID
29682
Beskrivning
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00410072
Länk
https://clinicaltrials.gov/show/NCT00410072
Nyckelord
Versioner (1)
- 2018-04-11 2018-04-11 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
11 april 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00410072
Eligibility Hepatitis B, Chronic NCT00410072
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B, Chronic NCT00410072
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
C0948827 (UMLS CUI [2])
Alanine aminotransferase increased
Item
alanine aminotransferase level ≥*upper limit of normal (uln) and ≤10*uln
boolean
C0151905 (UMLS CUI [1])
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])
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])