ID

39700

Description

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

Keywords

Versions (1)
  1. 2/10/20 2/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01226797

English

Eligibility Hepatitis C, Chronic NCT01226797

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv infection
Description

Hepatitis C, Chronic

Data type

boolean

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

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Description

Exclusion Criteria

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

Decompensated liver disease | Liver disease Severe

Data type

boolean

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

Liver Cirrhosis Biopsy of liver

Data type

boolean

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

INR raised

Data type

boolean

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

Elevated total bilirubin | Elevated serum unconjugated bilirubin

Data type

boolean

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

Serum albumin level decreased below normal

Data type

boolean

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

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

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

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

Data type

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).
Description

HIV Present

Data type

boolean

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

HBV coinfection

Data type

boolean

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

Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus

Data type

boolean

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

Eligibility Hepatitis C, Chronic NCT01226797

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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