Information:
Error:
ID
39566
Description
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam; ODM derived from: https://clinicaltrials.gov/show/NCT01886300
Link
https://clinicaltrials.gov/show/NCT01886300
Keywords
Versions (1)
- 1/29/20 1/29/20 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
January 29, 2020
DOI
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License
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01886300
Eligibility Hepatitis B, Chronic NCT01886300
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B, Chronic NCT01886300
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Hepatitis B e antigen positive | Hepatitis B, Chronic | Liver Cirrhosis | Liver Cirrhosis Absent
Item
hbeag-positive serologically proven chronic hepatitis b with or without cirrhosis
boolean
C0392390 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0524909 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Elevated serum alanine aminotransferase (ALT)
Item
elevated serum alt > uln (upper limit of normal) but </= 10 x uln
boolean
C4313265 (UMLS CUI [1])
Medical contraindication Absent Pegasys
Item
patients with no contra-indications to pegasys therapy as detailed in the label
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1176430 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,2])
C1176430 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent where local regulations allow or require it
boolean
C0021430 (UMLS CUI [1])
telbivudine
Item
patients should not receive concomitant therapy with telbivudine
boolean
C1453933 (UMLS CUI [1])
Coinfection Hepatitis A | HBV coinfection | HIV coinfection
Item
co-infection with hepatitis a, hepatitis b or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Depressive disorder | Mental disorders
Item
patients with depression/mental diseases
boolean
C0011581 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0004936 (UMLS CUI [2])
Neutrophil count
Item
neutrophil at baseline > 90.000/mm3
boolean
C0200633 (UMLS CUI [1])
T4 abnormal | Abnormal TSH level
Item
abnormal t4 or tsh
boolean
C0853626 (UMLS CUI [1])
C4476968 (UMLS CUI [2])
C4476968 (UMLS CUI [2])