ID

39700

Beschrijving

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes; ODM derived from: https://clinicaltrials.gov/show/NCT01226797

Link

https://clinicaltrials.gov/show/NCT01226797

Trefwoorden

  1. 10-02-20 10-02-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 februari 2020

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT01226797

Eligibility Hepatitis C, Chronic NCT01226797

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv infection
Beschrijving

Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
alt >1.5 but <10 times upper limit of normal
Beschrijving

Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated or severe liver disease defined by one or more of the following criteria:
Beschrijving

Decompensated liver disease | Liver disease Severe

Datatype

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
prior liver biopsy showing cirrhosis.
Beschrijving

Liver Cirrhosis Biopsy of liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0193388
international normalized ratio (inr) greater than or equal to 1.5.
Beschrijving

INR raised

Datatype

boolean

Alias
UMLS CUI [1]
C0853225
total bilirubin greater than or equal to 1.5x uln, or >2x uln for unconjugated bilirubin.
Beschrijving

Elevated total bilirubin | Elevated serum unconjugated bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0241024
serum albumin below normal.
Beschrijving

Serum albumin level decreased below normal

Datatype

boolean

Alias
UMLS CUI [1]
C3665623
alt or aspartate aminotransferase (ast) >10 x uln.
Beschrijving

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
Beschrijving

Hypertension, Portal | Splenomegaly | Ascites | Encephalopathy | Esophageal Varices

Datatype

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0038002
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0085584
UMLS CUI [5]
C0014867
presence of human immunodeficiency virus (hiv).
Beschrijving

HIV Present

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0150312
co-infection with hepatitis b virus (hbv).
Beschrijving

HBV coinfection

Datatype

boolean

Alias
UMLS CUI [1]
C2242656
co-infection with epstein barr virus (ebv) and/or cytomegalovirus (cmv).
Beschrijving

Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0014644
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0010825

Similar models

Eligibility Hepatitis C, Chronic NCT01226797

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt >1.5 but <10 times upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease | Liver disease Severe
Item
decompensated or severe liver disease defined by one or more of the following criteria:
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Liver Cirrhosis Biopsy of liver
Item
prior liver biopsy showing cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
INR raised
Item
international normalized ratio (inr) greater than or equal to 1.5.
boolean
C0853225 (UMLS CUI [1])
Elevated total bilirubin | Elevated serum unconjugated bilirubin
Item
total bilirubin greater than or equal to 1.5x uln, or >2x uln for unconjugated bilirubin.
boolean
C0741494 (UMLS CUI [1])
C0241024 (UMLS CUI [2])
Serum albumin level decreased below normal
Item
serum albumin below normal.
boolean
C3665623 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or aspartate aminotransferase (ast) >10 x uln.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Hypertension, Portal | Splenomegaly | Ascites | Encephalopathy | Esophageal Varices
Item
evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
boolean
C0020541 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
C0014867 (UMLS CUI [5])
HIV Present
Item
presence of human immunodeficiency virus (hiv).
boolean
C0019682 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
HBV coinfection
Item
co-infection with hepatitis b virus (hbv).
boolean
C2242656 (UMLS CUI [1])
Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus
Item
co-infection with epstein barr virus (ebv) and/or cytomegalovirus (cmv).
boolean
C0275524 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0010825 (UMLS CUI [2,2])

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