Recurrent disease | Prior Therapy Hepatitis C virus | peginterferon alfa-2a | peginterferon alfa-2b | Interferon-alpha | Ribavirin | Therapy naive
Item
relapsed subjects (parts 1 and 2) -- prior treatment for hcv with peg-ifn-alpha (or other ifn-alpha) and ribavirin for at least 12 weeks. naive subjects (part 3) -- no prior treatment with peg-ifn-alpha (or other ifn-alpha)
boolean
C0277556 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0391001 (UMLS CUI [3])
C0796545 (UMLS CUI [4])
C0002199 (UMLS CUI [5])
C0035525 (UMLS CUI [6])
C0919936 (UMLS CUI [7])
Hepatitis C virus RNA assay HCV genotype determination
Item
genotype 1 hcv rna greater than or equal to 100,000 iu/ml. mixed genotype hcv infection is not allowed
boolean
C1272251 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Biopsy of liver Ishak Score
Item
documented liver biopsy ≤2 years of study enrollment with ishak score ≤4
boolean
C0193388 (UMLS CUI [1,1])
C2986945 (UMLS CUI [1,2])
Absence Liver carcinoma Imaging of abdomen
Item
no evidence of hepatocellular carcinoma documented by abdominal imaging within 12 months of study entry
boolean
C0332197 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C2711454 (UMLS CUI [1,3])
Diastolic dysfunction Absent | Systolic dysfunction Absent | Echocardiogram normal | ECG normal
Item
no evidence of clinically significant diastolic or systolic dysfunction or other clinically significant abnormalities on echocardiogram or ecg
boolean
C0520863 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0749225 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0436484 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
Drug abuse test Negative | Alcohol use test Negative | Exception Drug Prescriptions
Item
negative drug and alcohol tests except for physician prescribed or approved medication
boolean
C0451130 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0679532 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0033081 (UMLS CUI [3,2])
Gender Contraceptive methods Quantity | Childbearing Potential Contraceptive methods Quantity
Item
if male, or female of child-bearing potential, agrees to use 2 forms of medically accepted contraception while on study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Hypersensitivity Interferon-alpha | Hypersensitivity Ribavirin
Item
history of hypersensitivity to ifn-alpha or ribavirin
boolean
C0020517 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Substance Use Disorders
Item
active substance abuse, such as alcohol, inhaled or injection drugs within the previous 6 months
boolean
C0038586 (UMLS CUI [1])
Operative Surgical Procedures | Blood product Received
Item
undergone surgery or received blood products within 30 days prior to study enrollment
boolean
C0543467 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Cardiomyopathy | Coronary Artery Disease | Angina Pectoris | Interventional procedure Coronary Artery Disease | Angioplasty | Placement of stent | Coronary Artery Bypass Surgery | Myocardial Infarction | Tachycardia, Ventricular
Item
prior history of cardiomyopathy, coronary artery disease including angina, interventive procedure for coronary artery disease including angioplasty, stent procedure or cardiac bypass surgery, prior myocardial infarction, or ventricular tachycardia
boolean
C0878544 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C1956346 (UMLS CUI [4,2])
C0162577 (UMLS CUI [5])
C0522776 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0042514 (UMLS CUI [9])
Hemoglobinopathy | Anemia, Hemolytic
Item
prior or current history of hemoglobinopathy or hemolytic anemia
boolean
C0019045 (UMLS CUI [1])
C0002878 (UMLS CUI [2])