Age
Item
male and female subjects, 18 to 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Therapy naive | Sustained Virologic Response failed | Status post PEGINTERFERON/RIBAVIRIN | Hepatitis C RNA Undetectable | Status post Treatment completed
Item
treatment-naive or subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (svr24) after at least 1 prior course of peg-ifn/rbv therapy of standard duration and had a documented undetectable hcv rna level at the planned end of treatment of at least 42-week duration
boolean
C0919936 (UMLS CUI [1])
C4050171 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1875630 (UMLS CUI [3,2])
C0855840 (UMLS CUI [4,1])
C3827727 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0580352 (UMLS CUI [5,2])
IL28B Genotype determination
Item
subjects have il28b cc genotype determined during screening
boolean
C1425475 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype | Hepatitis C Disease length | Hepatitis C virus Serologic test | Hepatitis C Antibodies Present | Hepatitis C virus RNA assay | Hepatitis C, Chronic | Fibrosis
Item
subjects have genotype 1 chronic hepatitis c and laboratory evidence of hcv infection for at least 6 months, defined by (1) documented hcv serology test at least 6 months before the first screening visit demonstrating the presence of anti-hcv antibody, or (2) documented presence of hcv rna by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis c demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. if only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0220847 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
C0166049 (UMLS CUI [4,1])
C0150312 (UMLS CUI [4,2])
C1272251 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
C0016059 (UMLS CUI [7])
Telaprevir Chronic Hepatitis C | Protease Inhibitors Chronic Hepatitis C
Item
subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis c
boolean
C1876229 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C0033607 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Sustained Virologic Response failed | Status post PEGINTERFERON/RIBAVIRIN | Hepatitis C RNA Undetectable failed
Item
subjects who did not achieve svr24 after at least 1 prior course of peg-ifn/rbv therapy of standard duration and never achieved undetectable hcv rna while on treatment
boolean
C4050171 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1875630 (UMLS CUI [2,2])
C0855840 (UMLS CUI [3,1])
C3827727 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Hepatic decompensation
Item
subjects have evidence of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Liver Cirrhosis
Item
subjects have evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Liver carcinoma | Liver carcinoma Suspected
Item
subjects have diagnosed or suspected hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Cause Liver disease | In addition to Hepatitis C | Malignant Neoplasm Hepatic Involvement | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis | Steatosis Asymptomatic allowed
Item
subjects have any other cause of significant liver disease in addition to hepatitis c, which may include but is not limited to malignancy with hepatic involvement, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. steatosis is allowed if clinically asymptomatic
boolean
C0015127 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0332287 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0441932 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4])
C1960179 (UMLS CUI [5])
C0023891 (UMLS CUI [6])
C0241910 (UMLS CUI [7])
C0018995 (UMLS CUI [8])
C0019202 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
C0152254 (UMLS CUI [12,1])
C0231221 (UMLS CUI [12,2])
C0683607 (UMLS CUI [12,3])