ID

17547

Description

Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00148863

Link

https://clinicaltrials.gov/show/NCT00148863

Keywords

  1. 9/22/16 9/22/16 -
Uploaded on

September 22, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT00148863

Eligibility Hepatitis C, Chronic NCT00148863

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
positive anti-hcv antibodies
Description

Hepatitis C Antibodies Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C1514241
positive hcv rna (quantitative method)
Description

HCV viral load Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1514241
previous treatment with peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months
Description

peginterferon alfa-2b Prior Therapy ended | Ribavirin Prior Therapy ended

Data type

boolean

Alias
UMLS CUI [1,1]
C0796545
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C2746065
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C2746065
without lower dosage during previous treatment
Description

peginterferon alfa-2b Prior Therapy Dosage | Ribavirin Prior Therapy Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0796545
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C0178602
non responder to the previous treatment with peg-interferon alpha 2b and ribavirin, with detectable hcv rna at w24 or decrease of less than 2 log10 copies/ml at w12 or decrease greater than 2 log10 but detectable hcv rna
Description

peginterferon alfa-2b Unresponsive to Treatment | Ribavirin Unresponsive to Treatment | HCV viral load Detectable | HCV viral load Decrease

Data type

boolean

Alias
UMLS CUI [1,1]
C0796545
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C1868902
UMLS CUI [3,2]
C3830527
UMLS CUI [4,1]
C1868902
UMLS CUI [4,2]
C0547047
metavir over f2 on the most recent biopsy
Description

Metavir score | Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C3888527
UMLS CUI [2]
C0005558
alt increase over normal value twice during last 6 months
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hiv infection
Description

HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0019693
psychiatric pathology
Description

Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
alcool consummation
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
pregnancy or plan of pregnancy
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147

Similar models

Eligibility Hepatitis C, Chronic NCT00148863

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Antibodies Positive
Item
positive anti-hcv antibodies
boolean
C0166049 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
HCV viral load Positive
Item
positive hcv rna (quantitative method)
boolean
C1868902 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
peginterferon alfa-2b Prior Therapy ended | Ribavirin Prior Therapy ended
Item
previous treatment with peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months
boolean
C0796545 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0035525 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C2746065 (UMLS CUI [2,3])
peginterferon alfa-2b Prior Therapy Dosage | Ribavirin Prior Therapy Dosage
Item
without lower dosage during previous treatment
boolean
C0796545 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0035525 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
peginterferon alfa-2b Unresponsive to Treatment | Ribavirin Unresponsive to Treatment | HCV viral load Detectable | HCV viral load Decrease
Item
non responder to the previous treatment with peg-interferon alpha 2b and ribavirin, with detectable hcv rna at w24 or decrease of less than 2 log10 copies/ml at w12 or decrease greater than 2 log10 but detectable hcv rna
boolean
C0796545 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1868902 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C1868902 (UMLS CUI [4,1])
C0547047 (UMLS CUI [4,2])
Metavir score | Biopsy
Item
metavir over f2 on the most recent biopsy
boolean
C3888527 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
Alanine aminotransferase increased
Item
alt increase over normal value twice during last 6 months
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Infections
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Mental disorders
Item
psychiatric pathology
boolean
C0004936 (UMLS CUI [1])
Alcohol consumption
Item
alcool consummation
boolean
C0001948 (UMLS CUI [1])
Liver Cirrhosis
Item
cirrhosis
boolean
C0023890 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnancy or plan of pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])

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