ID

42869

Description

Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00495131

Link

https://clinicaltrials.gov/show/NCT00495131

Keywords

Versions (2)
  1. 3/31/17 3/31/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00495131

English

Eligibility Hepatitis C, Chronic NCT00495131

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment naïve
Description

Therapy naive

Data type

boolean

Alias
UMLS CUI [1]
C0919936
age 18 and older than 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
Description

Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
detectable serum quantitative hcv-rna (cobas amplicor hcv monitor v2.0, roche molecular systems, pleasanton, ca) with dynamic range 600~<500,000 iu/ml
Description

Serum HCV viral load Quantitative Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C1868902
UMLS CUI [1,3]
C0392762
UMLS CUI [1,4]
C3830527
hcv genotype 1 (inno-lipa hcv ii, innogenetics, ghent, belgium)
Description

Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C1148363
serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
a liver biopsy consistent with the diagnosis of chronic hepatitis c
Description

Biopsy of liver Consistent with Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
Description

Anemia | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
neutropenia (neutrophil count <1,500 per cubic milliliter)
Description

Neutropenia | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0948762
thrombocytopenia (platelet <90,000 per cubic milliliter)
Description

Thrombocytopenia | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Description

HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
chronic alcohol abuse (daily consumption > 20 gram per day)
Description

Alcoholic Intoxication, Chronic | Alcohol consumption Grams per day

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
decompensated liver disease (child-pugh class b or c)
Description

Decompensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C4050412
serum creatinine level more than 1.5 times the upper limit of normal
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
autoimmune liver disease
Description

Autoimmune liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0400936
neoplastic disease
Description

Neoplastic disease

Data type

boolean

Alias
UMLS CUI [1]
C1882062
an organ transplant
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
immunosuppressive therapy
Description

Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
Description

Autoimmune Diseases Poorly controlled | Lung diseases | Heart Diseases | Mental disorders | nervous system disorder | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0011849
evidence of drug abuse
Description

Drug abuse Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0332120
unwilling to have contraception
Description

Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Hepatitis C, Chronic NCT00495131

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive
Item
treatment naïve
boolean
C0919936 (UMLS CUI [1])
Age
Item
age 18 and older than 18 years old
boolean
C0001779 (UMLS CUI [1])
Hepatitis C antibody positive
Item
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
boolean
C0281863 (UMLS CUI [1])
Serum HCV viral load Quantitative Detectable
Item
detectable serum quantitative hcv-rna (cobas amplicor hcv monitor v2.0, roche molecular systems, pleasanton, ca) with dynamic range 600~<500,000 iu/ml
boolean
C0229671 (UMLS CUI [1,1])
C1868902 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
Hepatitis C virus genotype
Item
hcv genotype 1 (inno-lipa hcv ii, innogenetics, ghent, belgium)
boolean
C1148363 (UMLS CUI [1])
Alanine aminotransferase increased
Item
serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
boolean
C0151905 (UMLS CUI [1])
Biopsy of liver Consistent with Chronic Hepatitis C
Item
a liver biopsy consistent with the diagnosis of chronic hepatitis c
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Anemia | Hemoglobin measurement | Gender
Item
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Neutropenia | Absolute neutrophil count
Item
neutropenia (neutrophil count <1,500 per cubic milliliter)
boolean
C0027947 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet <90,000 per cubic milliliter)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Alcohol consumption Grams per day
Item
chronic alcohol abuse (daily consumption > 20 gram per day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Serum creatinine raised
Item
serum creatinine level more than 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Autoimmune liver disease
Item
autoimmune liver disease
boolean
C0400936 (UMLS CUI [1])
Neoplastic disease
Item
neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Organ Transplantation
Item
an organ transplant
boolean
C0029216 (UMLS CUI [1])
Therapeutic immunosuppression
Item
immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1])
Autoimmune Diseases Poorly controlled | Lung diseases | Heart Diseases | Mental disorders | nervous system disorder | Diabetes Mellitus
Item
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
boolean
C0004364 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
Drug abuse Evidence of
Item
evidence of drug abuse
boolean
C0013146 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Contraceptive methods Unwilling
Item
unwilling to have contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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