Information:
Fel:
ID
13713
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT01447394
Nyckelord
Versioner (1)
- 2016-02-29 2016-02-29 -
Uppladdad den
29 februari 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis C Virus (HCV) NCT01447394
Eligibility Hepatitis C Virus (HCV) NCT01447394
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C Virus (HCV) NCT01447394
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
C0019196 (UMLS CUI [1,2])
infection hepatitis c
Item
infected with hcv other than genotype 1 or 4
boolean
C3714514 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
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])
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])
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])
C0005558 (UMLS CUI [2])