Chronic Hepatitis C Genotype | Hepatitis C antibody positive | Hepatitis C RNA positive | Hepatitis c viral genotype Positive
Item
subjects chronically infected with hcv genotype 1 as documented by: positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0281863 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
C4272868 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10*5* iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Prior Therapy | Interferon Formulation | Interferon-alpha | peginterferon alfa-2a | Ribavirin
Item
less than 4 weeks total prior therapy with an ifn formulation (ie, ifnα, pegifnα-2a), or rbv and no exposure to ifn or rbv within 24 weeks of randomization
boolean
C1514463 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0002199 (UMLS CUI [3])
C0391001 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
Liver Cirrhosis Absent Biopsy
Item
results of a biopsy obtained ≤ 24 months prior to randomization showing no evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) of 18 to 35 kg/m², inclusive. bmi = weight (kg)/ [height (m)]²
boolean
C1305855 (UMLS CUI [1])
ID.6
Item
at screening
boolean
Recipient Liver transplant
Item
liver transplant recipients
boolean
C1709854 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
Liver carcinoma Imaging | Liver carcinoma Suspected Imaging | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver
Item
documented or suspected hcc by imaging or liver biopsy
boolean
C2239176 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Medical condition Associated with Chronic liver disease | Exception Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Liver disease Metabolic | Alcoholic Liver Disease | Exposure to Toxin
Item
evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0311400 (UMLS CUI [5,2])
C0023896 (UMLS CUI [6])
C0332157 (UMLS CUI [7,1])
C0040549 (UMLS CUI [7,2])
Hepatitis B, Chronic | Hepatitis b serology | Hepatitis B Surface Antigens Seropositive | Hepatitis B resolved | Hepatitis B Virus Surface Antibody Seropositive
Item
history of chronic hepatitis b virus (hbv) as documented by hbv serologies (eg. hbsag-seropositive). patients with resolved hbv infection may participate (eg. hbsab-seropositive)
boolean
C0524909 (UMLS CUI [1])
C0744837 (UMLS CUI [2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C1514893 (UMLS CUI [4,2])
C0369334 (UMLS CUI [5,1])
C0521143 (UMLS CUI [5,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])