Transplantation of liver
Item
liver transplant between 6 months and 10 years prior to the screening visit
boolean
C0023911 (UMLS CUI [1])
Hepatitis C Genotype
Item
hepatitis c virus (hcv) genotype 1 subtype b infection confirmed at screening
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
screening hcv ribose nucleic acid level greater than 10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Therapy naive Hepatitis C | Therapeutic procedure Absent Post Orthotopic liver transplant | Pharmacotherapy Absent Hepatitis C | Investigational New Drugs Absent Hepatitis C
Item
hcv treatment-naïve participants must not have received post orthotopic liver transplant treatment with any approved or investigational drug for the treatment of hcv
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0400447 (UMLS CUI [2,4])
C0013216 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
Immunosuppressant drug therapy Stable | Dose unchanged | Cyclosporine | Tacrolimus
Item
receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine (only allowed in part 1) or tacrolimus for more than 3 months prior to the screening visit
boolean
C1096650 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0010592 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
Hepatic decompensation | Hepatic decompensation chronic | Status post Transplantation of liver | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1])
C1394798 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
C0003962 (UMLS CUI [4])
C0333106 (UMLS CUI [5])
C0019151 (UMLS CUI [6])
Liver disease | Etiology Except HCV | Graft Rejection | Exception Hepatic steatosis Present
Item
any liver disease of non-hcv etiology, including current evidence of graft rejection except the presence of liver steatosis
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0018129 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0015695 (UMLS CUI [4,2])
C0150312 (UMLS CUI [4,3])
Disease Clinical Significance | Exacerbation Due to Ribavirin
Item
any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavirin
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
HCV coinfection Genotype | Coinfection HIV-1 | Coinfection HIV-2 | Human immunodeficiency virus type 1 antibody Positive | HIV-2 Antibody Positive | HBV coinfection | Hepatitis B surface antigen positive
Item
coinfection with hcv of another genotype than genotype 1b, hiv type 1 or 2 (positive hiv-1 or hiv-2 antibodies test at screening), and hepatitis b virus (hepatitis b surface antigen positive)
boolean
C1698259 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019704 (UMLS CUI [2,2])
C0275524 (UMLS CUI [3,1])
C0019707 (UMLS CUI [3,2])
C0369497 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0373917 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C2242656 (UMLS CUI [6])
C0149709 (UMLS CUI [7])
Organ Transplantation multiple | Heart | Lung | Pancreas | Kidney
Item
multi-organ transplant that included heart, lung, pancreas, or kidney
boolean
C0029216 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0018787 (UMLS CUI [2])
C0024109 (UMLS CUI [3])
C0030274 (UMLS CUI [4])
C0022646 (UMLS CUI [5])