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

Lien

https://clinicaltrials.gov/show/NCT01886300

Mots-clés

  1. 29/01/2020 29/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

29 janvier 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Hepatitis B, Chronic NCT01886300

Eligibility Hepatitis B, Chronic NCT01886300

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
hbeag-positive serologically proven chronic hepatitis b with or without cirrhosis
Description

Hepatitis B e antigen positive | Hepatitis B, Chronic | Liver Cirrhosis | Liver Cirrhosis Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0023890
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0332197
elevated serum alt > uln (upper limit of normal) but </= 10 x uln
Description

Elevated serum alanine aminotransferase (ALT)

Type de données

boolean

Alias
UMLS CUI [1]
C4313265
patients with no contra-indications to pegasys therapy as detailed in the label
Description

Medical contraindication Absent Pegasys

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1176430
written informed consent where local regulations allow or require it
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients should not receive concomitant therapy with telbivudine
Description

telbivudine

Type de données

boolean

Alias
UMLS CUI [1]
C1453933
co-infection with hepatitis a, hepatitis b or hiv
Description

Coinfection Hepatitis A | HBV coinfection | HIV coinfection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019159
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with depression/mental diseases
Description

Depressive disorder | Mental disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0004936
neutrophil at baseline > 90.000/mm3
Description

Neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0200633
abnormal t4 or tsh
Description

T4 abnormal | Abnormal TSH level

Type de données

boolean

Alias
UMLS CUI [1]
C0853626
UMLS CUI [2]
C4476968

Similar models

Eligibility Hepatitis B, Chronic NCT01886300

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
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])
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])
Informed Consent
Item
written informed consent where local regulations allow or require it
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Depressive disorder | Mental disorders
Item
patients with depression/mental diseases
boolean
C0011581 (UMLS CUI [1])
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])

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