Body Weight
Item
is ≥ 40 kg and ≤ 125 kg.
boolean
C0005910 (UMLS CUI [1])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
documented chc genotype 1 with hcv rna ≥10,000 international units (iu)/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
IL-28B
Item
has il-28b cc allele gene
boolean
C3815173 (UMLS CUI [1])
Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver disease Stage Fibroscan | Liver disease Stage FibroTest Score
Item
has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and fibrotest can also be used for staging of liver disease).
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4,1])
C1306673 (UMLS CUI [4,2])
C3642160 (UMLS CUI [4,3])
HIV coinfection | HBV coinfection | Hepatitis B surface antigen positive | HIV Seropositivity
Item
co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hepatitis b surface antigen [hbsag] or hiv positive).
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
Interferon | Ribavirin | HCV DIRECT ACTING ANTIVIRALS
Item
previously treated with an interferon and ribavirin regimen or hcv direct acting antiviral regimen.
boolean
C3652465 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0220847 (UMLS CUI [3,1])
C3653501 (UMLS CUI [3,2])
Investigational New Drugs Hepatitis C | Herbal medicine Associated with Hepatotoxicity
Item
treatment for hepatitis c with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
boolean
C0013230 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C2240391 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0235378 (UMLS CUI [2,3])
Pharmaceutical Preparations Relationship Cytochrome P-450 CYP3A4 | Pharmaceutical Preparations Relationship Cytochrome P-450 CYP3A5 | Plasma concentration Associated with Life Threatening Adverse Event
Item
receiving any medication(s) within 2 weeks prior to the day 1 visit that are highly dependent on cytochrome p450 3a4 (cyp3a4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
boolean
C0013227 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C3714750 (UMLS CUI [2,3])
C0683150 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C1517874 (UMLS CUI [3,3])
Study Subject Participation Status | Clinical Trial
Item
participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Decompensated liver disease | Liver carcinoma
Item
evidence of decompensated liver disease or hepatocellular carcinoma (hcc)
boolean
C4075847 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Diabetic | Hypertensive | Retinal Disease
Item
is diabetic and/or hypertensive with significant retinopathy
boolean
C0241863 (UMLS CUI [1])
C0857121 (UMLS CUI [2])
C0035309 (UMLS CUI [3])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial | Immune System Disease | Chronic lung disease | Cardiac abnormalities | Cardiac dysfunction
Item
has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0021053 (UMLS CUI [3])
C0746102 (UMLS CUI [4])
C0018798 (UMLS CUI [5])
C3277906 (UMLS CUI [6])
Malignant Neoplasm | Malignant Neoplasm Suspected | History of malignant neoplasm
Item
evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0455471 (UMLS CUI [3])
Hemoglobin measurement | Gender
Item
hemoglobin <12 g/dl for females and <13 g/dl for males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Neutrophil count | African descent
Item
neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of african descent
boolean
C0200633 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Platelet Count measurement
Item
platelets <150,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Direct bilirubin increased
Item
direct bilirubin >1.5 x upper limit of normal (uln) of the laboratory reference range.
boolean
C0740434 (UMLS CUI [1])