Age
Item
males and females 18-70 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis C, Chronic
Item
chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
Biopsy of liver | Indication Absence Liver Cirrhosis
Item
subjects must have liver biopsy results (≤ 2 years prior to screening) indicating the absence of cirrhosis.
boolean
C0193388 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023890 (UMLS CUI [2,3])
Hepatitis C Genotype
Item
monoinfection with hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna > 10^4 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Therapy naive Hepatitis C virus
Item
hcv treatment naïve
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
Patient Appropriate PEGINTERFERON/RIBAVIRIN
Item
candidate for peg/rbv therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1875630 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) 18-36 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative
Item
agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have negative pregnancy test at screening and baseline.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Pregnancy | Gender Partner Pregnancy
Item
pregnant female or male with pregnant female partner
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Leukopenia Severe | Neutropenia Severe | Anemia Severe | Thrombocytopenia Severe | Increased thyroid-stimulating hormone (TSH)
Item
exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh)
boolean
C0023530 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027947 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002871 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0040034 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1968707 (UMLS CUI [5])
Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Liver carcinoma | Malignant Neoplasms | Exception Skin carcinoma resolved | Hemoglobinopathy | Retinal Diseases | Immunosuppressed patient
Item
diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
boolean
C0004364 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C0554876 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0730607 (UMLS CUI [5])
C0019682 (UMLS CUI [6])
C0019169 (UMLS CUI [7])
C2239176 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0699893 (UMLS CUI [10,2])
C1514893 (UMLS CUI [10,3])
C0019045 (UMLS CUI [11])
C0035309 (UMLS CUI [12])
C0085393 (UMLS CUI [13])
Amphetamines | Cocaine | Opiates | Morphine | Heroin | Alcohol abuse | Exception Methadone Stable | Exception Buprenorphine Maintenance therapy
Item
subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening may be included into the study.
boolean
C0002667 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0376196 (UMLS CUI [3])
C0026549 (UMLS CUI [4])
C0011892 (UMLS CUI [5])
C0085762 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0025605 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0006405 (UMLS CUI [8,2])
C0677908 (UMLS CUI [8,3])