ID

13713

Beschrijving

Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01447394

Link

https://clinicaltrials.gov/show/NCT01447394

Trefwoorden

  1. 29-02-16 29-02-16 -
Geüploaded op

29 februari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C Virus (HCV) NCT01447394

Eligibility Hepatitis C Virus (HCV) NCT01447394

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, genotype 1 or 4
Beschrijving

chronic hepatitis c

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
hcv ribonucleic acid (rna) ≥ 100,000 iu/ml at screening
Beschrijving

Hepatitis C virus RNA

Datatype

boolean

Alias
UMLS CUI [1]
C0369335
liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. subjects with compensated cirrhosis can enroll and will be capped at 10%
Beschrijving

liver biopsy; cirrhosis; staging

Datatype

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0432488
naive to prior anti-hcv therapy
Beschrijving

Therapy naive Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
infected with hcv other than genotype 1 or 4
Beschrijving

infection hepatitis c

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0220847
positive hepatitis b surface antigen (hbsag), or human immunodeficiency virus-1 (hiv-1)/hiv-2 antibody or hepatitis d virus (hdv) at screening
Beschrijving

Hepatitis B surface antigen positive; serum HIV antibody test; screening

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C2229753
UMLS CUI [3]
C0220908
evidence of liver disease other than hcv
Beschrijving

liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
active substance abuse
Beschrijving

Substance Use Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
use of hematologic growth factors within 90 days prior to study randomization
Beschrijving

growth factors hematologic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C0205488
evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Beschrijving

decompensated cirrhosis; biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C0005558

Similar models

Eligibility Hepatitis C Virus (HCV) NCT01447394

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
chronic hepatitis c
Item
chronic hepatitis c, genotype 1 or 4
boolean
C0524910 (UMLS CUI [1])
Hepatitis C virus RNA
Item
hcv ribonucleic acid (rna) ≥ 100,000 iu/ml at screening
boolean
C0369335 (UMLS CUI [1])
liver biopsy; cirrhosis; staging
Item
liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. subjects with compensated cirrhosis can enroll and will be capped at 10%
boolean
C0193388 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0432488 (UMLS CUI [3])
Therapy naive Hepatitis C
Item
naive to prior anti-hcv therapy
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
infection hepatitis c
Item
infected with hcv other than genotype 1 or 4
boolean
C3714514 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
Hepatitis B surface antigen positive; serum HIV antibody test; screening
Item
positive hepatitis b surface antigen (hbsag), or human immunodeficiency virus-1 (hiv-1)/hiv-2 antibody or hepatitis d virus (hdv) at screening
boolean
C0149709 (UMLS CUI [1])
C2229753 (UMLS CUI [2])
C0220908 (UMLS CUI [3])
liver disease
Item
evidence of liver disease other than hcv
boolean
C0023895 (UMLS CUI [1])
Substance Use Disorder
Item
active substance abuse
boolean
C0038586 (UMLS CUI [1])
growth factors hematologic
Item
use of hematologic growth factors within 90 days prior to study randomization
boolean
C0018284 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
decompensated cirrhosis; biopsy
Item
evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
boolean
C1619727 (UMLS CUI [1])
C0005558 (UMLS CUI [2])

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