Age
Item
male or female subjects at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
HCV Seropositive
Item
hcv seropositive.
boolean
C0220847 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna >10,000 iu/ml at screening.
boolean
C1272251 (UMLS CUI [1])
Hepatitis C Genotype
Item
hcv genotype 1. subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Absence Interferon-alpha plus Ribavirin | Absence Anti-hepatitis C (HCV) Agents Investigational
Item
treatment naïve (no prior treatment with ifn alfa +/ rbv regimens or investigational anti-hcv agents).
boolean
C0919936 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0002199 (UMLS CUI [2,2])
C0332287 (UMLS CUI [2,3])
C0035525 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C4324240 (UMLS CUI [3,2])
C1517586 (UMLS CUI [3,3])
Biopsy of liver | Fibrosis Without Liver Cirrhosis
Item
liver biopsy within two years (24 months) of screening with non-cirrhotic fibrosis classification. for those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
boolean
C0193388 (UMLS CUI [1])
C0016059 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0023890 (UMLS CUI [2,3])
Ultrasonography | Bridging fibrosis | Alpha one fetoprotein measurement | Liver carcinoma Absent
Item
ultrasound within 6 months of screening for 1) those subjects with bridging fibrosis or 2) those subjects with afp >50 and <100 ng/ml with no evidence of hepatocellular carcinoma. for those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.
boolean
C0041618 (UMLS CUI [1])
C0334160 (UMLS CUI [2])
C0201539 (UMLS CUI [3])
C2239176 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
HIV coinfection | HBV coinfection
Item
co-infection with either hiv or hbv.
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Liver disease Severe | Decompensated liver disease
Item
evidence of severe or decompensated liver disease.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
Liver disease | Relationship Absent Hepatitis C
Item
subjects with liver disease unrelated to hcv infection.
boolean
C0023895 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Medical condition Pre-existing | Study Subject Inappropriate PEGINTERFERON/RIBAVIRIN
Item
pre-existing medical condition that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling.
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1875630 (UMLS CUI [2,3])
Laboratory test result abnormal | Study Subject Inappropriate PEGINTERFERON/RIBAVIRIN
Item
laboratory abnormality at screening that makes the subject unsuitable for treatment with pegifn/rbv therapy per product labeling.
boolean
C0438215 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1875630 (UMLS CUI [2,3])
ECG abnormal Suggestive of Heart Disease | ECG abnormal Suggestive of Prolonged QTc interval
Item
abnormal ecg suggestive of clinically significant cardiac disease or qtc>450msec.
boolean
C0522055 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
Organ Transplantation
Item
history of organ transplant.
boolean
C0029216 (UMLS CUI [1])
Pharmaceutical Preparations Contraindicated | CYP3A4 Inhibitors Strong | CYP3A4 Substrate Sensitive | CYP3A4 Substrate Therapeutic range Limited | CYP3A4 Inducers
Item
contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent cyp3a4 inhibitors, sensitive cyp3a4 substrates, cyp3a4 substrates with narrow therapeutic range and cyp3a4 inducers.
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C3850053 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0332324 (UMLS CUI [3,3])
C3714798 (UMLS CUI [4,1])
C3891814 (UMLS CUI [4,2])
C0460097 (UMLS CUI [4,3])
C0439801 (UMLS CUI [4,4])
C3850041 (UMLS CUI [5])
Substance Use Disorders Preventing Adherence Investigational New Drugs | Substance Use Disorders Preventing Follow-up
Item
active alcohol or substance abuse sufficient, in the investigator's judgment, to prevent adherence to study medication and/or follow up.
boolean
C0038586 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0038586 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
males whose female partner is pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])