Age | Chronic Hepatitis C Compensated | Hepatitis C antibody positive | Hepatitis C RNA positive
Item
male or female, at least 18 years of age and no older than 65 years with compensated chronic hcv infection based on a history of positive serum anti-hcv antibody and/or hcv rna
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
C0281863 (UMLS CUI [3])
C0855842 (UMLS CUI [4])
Hepatitis C virus genotype determination
Item
diagnosed with hcv genotype 1, 4, 5 or 6 as determined during the screening visit
boolean
C1533728 (UMLS CUI [1])
Pegintron Dose | Pegasys Dose | Ribavirin Dose | Body Weight | Patient need for Compliance behavior Percentage | PEGINTERFERON/RIBAVIRIN
Item
the starting doses in the initial treatment must have been 1.5 μg/kg/week peg-intron or 180 μg/week pegasys, and 1000/1200 mg/day ribavirin based on body weight. patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
boolean
C1527737 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1176430 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0005910 (UMLS CUI [4])
C0686904 (UMLS CUI [5,1])
C1321605 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
C1875630 (UMLS CUI [6])
Biopsy of liver Fibrosis score
Item
liver biopsy indicating f0-f4 must be performed within 3 years prior to screening. documentation of the results of the biopsy must be available. if documentation is not available, a liver biopsy must be performed during the screening period. (a maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of f4)
boolean
C0193388 (UMLS CUI [1,1])
C1954437 (UMLS CUI [1,2])
Partial response | Therapeutic procedure Patient Therapy naive | Peginterferon alfa-2a Course Quantity | Pegasys Course Quantity | Peginterferon alfa-2b Course Quantity | Pegintron Course Quantity | Ribavirin Course Quantity
Item
documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (pegasys) and ribavirin or peginterferon alfa-2b (peg-intron) and ribavirin
boolean
C1521726 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0919936 (UMLS CUI [2,3])
C0391001 (UMLS CUI [3,1])
C0750729 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1176430 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0796545 (UMLS CUI [5,1])
C0750729 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1527737 (UMLS CUI [6,1])
C0750729 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0035525 (UMLS CUI [7,1])
C0750729 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
Hepatitis C virus RNA Detectable | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Hepatitis C RNA decreased
Item
detectable hcv rna after 12 weeks if initial peginterferon alfa/ribavirin therapy and <2 log decrease in hcv rna at week 12 from baseline.
boolean
C0369335 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2])
C0796545 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C2363763 (UMLS CUI [5])
Hepatitis C virus genotype determination
Item
hcv genotype 2 or 3
boolean
C1533728 (UMLS CUI [1])
Neuropsychiatric syndrome Severe
Item
severe neuropsychiatric disorder.
boolean
C3203509 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Metabolic Disease | Hematological Disease | Lung disease | Myocardial Ischemia | Heart Disease | Heart Disease Unstable | Gastrointestinal Diseases | Nervous system disorder | Kidney Diseases | Urologic Diseases | Endocrine System Diseases | Disorder of eye | Retinal Diseases Severe | Immune System Diseases
Item
history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
boolean
C0025517 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0017178 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0042075 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0015397 (UMLS CUI [12])
C0035309 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0021053 (UMLS CUI [14])
HIV Infection | HIV Seropositivity
Item
known hiv infection or positive hiv at screening.
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Disease
Item
underlying autoimmune disease
boolean
C0004364 (UMLS CUI [1])