ID

21428

Description

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC); ODM derived from: https://clinicaltrials.gov/show/NCT00304551

Link

https://clinicaltrials.gov/show/NCT00304551

Keywords

  1. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Liver Cirrhosis NCT00304551

Eligibility Liver Cirrhosis NCT00304551

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 20 to 75 years-old with quantifiable serum hcv-rna (≥ 500 iu/ml), elevated serum alanine aminotransferase activity (≥ 45 iu per liter) within sixty days of screening, and proven chc with compensated lc (child-pugh a) on liver biopsy.
Description

Age, serum hcv-rna, alanine aminotransferase measurement, liver biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1868902
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0193388
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
Description

Platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
anemia (less than 12 g hemoglobin per deciliter )
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
hepatitis b co-infection; decompensated liver disease.
Description

Hepatitis b co-infection, decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4075847
organ transplant
Description

Organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0029216
creatinine clearance less than 50 milliliters per minute
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
poorly controlled psychiatric disease
Description

Mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
poorly controlled diabetes
Description

Diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
malignant neoplastic disease
Description

Malignant neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
severe cardiac or chronic pulmonary disease
Description

Cardiac or pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
immunologically mediated disease
Description

Immunologically mediated disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
retinopathy
Description

Retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0035309

Similar models

Eligibility Liver Cirrhosis NCT00304551

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age, serum hcv-rna, alanine aminotransferase measurement, liver biopsy
Item
patients aged 20 to 75 years-old with quantifiable serum hcv-rna (≥ 500 iu/ml), elevated serum alanine aminotransferase activity (≥ 45 iu per liter) within sixty days of screening, and proven chc with compensated lc (child-pugh a) on liver biopsy.
boolean
C0001779 (UMLS CUI [1])
C1868902 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0193388 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Neutrophil count
Item
patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
boolean
C0200633 (UMLS CUI [1])
Platelets
Item
thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
boolean
C0005821 (UMLS CUI [1])
Hemoglobin measurement
Item
anemia (less than 12 g hemoglobin per deciliter )
boolean
C0518015 (UMLS CUI [1])
Hepatitis b co-infection, decompensated liver disease
Item
hepatitis b co-infection; decompensated liver disease.
boolean
C2242656 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
Organ transplant
Item
organ transplant
boolean
C0029216 (UMLS CUI [1])
Creatinine clearance
Item
creatinine clearance less than 50 milliliters per minute
boolean
C0373595 (UMLS CUI [1])
Mental disorder
Item
poorly controlled psychiatric disease
boolean
C0004936 (UMLS CUI [1])
Diabetes mellitus
Item
poorly controlled diabetes
boolean
C0011849 (UMLS CUI [1])
Malignant neoplasms
Item
malignant neoplastic disease
boolean
C0006826 (UMLS CUI [1])
Cardiac or pulmonary disease
Item
severe cardiac or chronic pulmonary disease
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Immunologically mediated disease
Item
immunologically mediated disease
boolean
C0004364 (UMLS CUI [1])
Retinopathy
Item
retinopathy
boolean
C0035309 (UMLS CUI [1])

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