Adult | Age
Item
adult subjects (18-60 years of age or up to 64 years of age with approval)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Duration | Hepatitis C virus RNA assay Plasma
Item
documented chronic hcv infection to be of at least 6 months duration and plasma hcv rna ≥ 5 log10 iu/ml at screening.
boolean
C0524910 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
Therapy naive Hepatitis C
Item
hcv treatment naïve
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Creatinine clearance measurement Estimated
Item
estimated creatinine clearance ≥ 80 ml/min,
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
QTc interval Fridericia's Correction Formula | QRS duration | PR interval duration
Item
qtcf interval ≤ 450 msec, qrs duration < 100 msec, pr interval < 220 msec,
boolean
C0489625 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C0429025 (UMLS CUI [2])
C0429024 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) of 19.0 to 34.0 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Therapy naive Hepatitis C
Item
eligible subjects must also be hcv treatment-naïve.
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Liver Cirrhosis | Alcohol intake above recommended sensible limits | Liver carcinoma | Alpha one fetoprotein measurement | Standard of Care Measurement
Item
subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/ml or by any other standard of care measure)
boolean
C0023890 (UMLS CUI [1])
C0560219 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
C0201539 (UMLS CUI [4])
C2936643 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
Urine drug screen positive Illicit Drugs
Item
urine drug screen positive for illicit/illegal drugs
boolean
C0743300 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt and ast levels > 5 times the upper limit of the normal range (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Direct bilirubin increased | Hepatic decompensation | Platelet Count measurement | Prothrombin time increased | Albumin measurement
Item
direct bilirubin > uln, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × uln and albumin < 3.5 g/dl) are not eligible for study participation.
boolean
C0740434 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0151872 (UMLS CUI [4])
C0201838 (UMLS CUI [5])
Absolute neutrophil count | African American | Hemoglobin measurement
Item
subjects with an absolute neutrophil count (anc) < 1,000 cells/mm3 (< 750 cells/mm3 for black or african-american subjects), hemoglobin (hb) < 11 g/dl,
boolean
C0948762 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
HBV coinfection | Human immunodeficiency virus (HIV) coinfection | HCV coinfection | Exception Hepatitis C virus genotype
Item
coinfected with hepatitis b virus (hbv), human immunodeficiency virus (hiv), or another hcv genotype (other than type 1 for cohorts 1-5 and type 2 or 3 for cohort 6) are not eligible for study participation.
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1533728 (UMLS CUI [4,2])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Sign Decompensated liver disease | Prothrombin time increased | Platelet Count measurement | Albumin measurement | Hepatic decompensation | Ascites | Icterus | Encephalopathy | Bleeding varices
Item
any sign of decompensated liver disease, including prothrombin time ≥ 1.5 x uln, platelets < 100,000/mm3 or albumin < 3.5 g/dl at screening or current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
boolean
C0311392 (UMLS CUI [1,1])
C4075847 (UMLS CUI [1,2])
C0151872 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C1394798 (UMLS CUI [5])
C0003962 (UMLS CUI [6])
C0022346 (UMLS CUI [7])
C0085584 (UMLS CUI [8])
C0333106 (UMLS CUI [9])
Illness Clinical Significance Interferes with Therapeutic procedure | Disease Major Interferes with Therapeutic procedure | Illness Clinical Significance Interferes with Assessment | Disease Major Interferes with Assessment | Illness Clinical Significance Interferes with Protocol Compliance | Disease Major Interferes with Protocol Compliance
Item
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1516048 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1516048 (UMLS CUI [4,4])
C0221423 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
Gastrointestinal Disease Interferes with Absorption Investigational New Drug | Gastrointestinal Disease Interferes with Anatomy gastrointestinal | Gastrointestinal Disease Interferes with Gastrointestinal Motility
Item
history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0700276 (UMLS CUI [2,3])
C0521362 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])