chronic hepatitis c
Item
chronic genotype 1 hepatitis c virus (hcv) infection
boolean
C0524910 (UMLS CUI [1])
plasma hepatitis c virus rna
Item
plasma hcv rna of more than 10,000 iu/ml at screening
boolean
C1977893 (UMLS CUI [1])
therapy ribavirin; therapy response for hepatitis c virus infection
Item
patients in cohort 1 must be null responders to pegifn/ribavirin with at least 1 documented previous course of pegifn/ribavirin therapy for at least 12 consecutive weeks
boolean
C0087111 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C2750389 (UMLS CUI [2])
therapy response for hepatitis c virus infection; Therapy naive Hepatitis C
Item
patients in cohort 2 must be null responders to pegifn/ribavirin with at least 1 documented previous course of pegifn/ribavirin therapy for at least 12 consecutive weeks and could also be hcv treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of hcv
boolean
C2750389 (UMLS CUI [1])
C0919936 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
hepatitis c virus; cohort; no response to treatment
Item
null responders patients in cohort 1 and cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 iu/ml reduction in hcv rna from baseline at week 12 of the most recent pegifn/ribavirin therapy
boolean
C0220847 (UMLS CUI [1])
C0599755 (UMLS CUI [2])
C0184782 (UMLS CUI [3])
liver biopsy; screening; metavir fibrosis score
Item
patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed metavir f3 or f4 fibrosis
boolean
C0193388 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
C3897040 (UMLS CUI [3])
contraception
Item
must agree to use 2 forms of effective contraception throughout the study (male and female)
boolean
C0700589 (UMLS CUI [1])
hepatic decompensation
Item
has evidence of hepatic decompensation
boolean
C0085605 (UMLS CUI [1])
liver disease; etiology
Item
has any liver disease of non-hcv etiology
boolean
C0023895 (UMLS CUI [1])
C1314792 (UMLS CUI [2])
HCV coinfection; hcv genotype
Item
has an infection/co-infection with non-genotype 1 hcv
boolean
C1698259 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
coinfection hiv; hiv antibody test
Item
has a co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibody test at screening)
boolean
C0019682 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2229753 (UMLS CUI [2])
HBV coinfection; Hepatitis B surface antigen positive
Item
has a co-infection with hepatitis b virus (hepatitis b surface antigen [hbsag] positive)
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
medical history malignancy
Item
has a history of malignancy within 5 years of the screening visit
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])