HCV viral load Level Branched DNA Assay
Item
a serum hcv rna level of >100,000 iu/ml using a quantitative, branched-chain-dna (bdna)-based assay (lower limit of quantitation = ~650 iu/ml) or other equally sensitive quantitative methods.
boolean
C1868902 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0887812 (UMLS CUI [1,3])
Hepatitis C virus genotype Infection
Item
infection with genotype 1 hcv
boolean
C1148363 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Absence of therapeutic response | Response Viral Early Absent | HCV viral load Reduction | HCV viral load Undetectable | Hepatitis C RNA positive | pegylated interferon alfa | Ribavirin | Therapeutic procedure Hepatitis C
Item
documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (evr) (≥2 log reduction in serum hcv rna or undetectable hcv rna after 12 weeks of treatment) or is serum hcv rna positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis c.
boolean
C0521983 (UMLS CUI [1])
C0871261 (UMLS CUI [2,1])
C0521026 (UMLS CUI [2,2])
C1279919 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C1868902 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C1868902 (UMLS CUI [4,1])
C3827727 (UMLS CUI [4,2])
C0855842 (UMLS CUI [5])
C0907160 (UMLS CUI [6])
C0035525 (UMLS CUI [7])
C0087111 (UMLS CUI [8,1])
C0019196 (UMLS CUI [8,2])
Childbearing Potential Contraceptive methods Quantity | Infertility | Postmenopausal state | Menstrual cycle Absent Duration
Item
women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0021359 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0025329 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
Gender Sex Behavior Contraceptive methods
Item
sexually active male subjects are practicing acceptable methods of contraception during trial participation
boolean
C0079399 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Subcutaneous Injections Self Administration Daily | Caregiver Subcutaneous Injections Administration Daily
Item
the subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
boolean
C0021499 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0021499 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Liver Cirrhosis Evidence of
Item
clinical, laboratory, or histological evidence of liver cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Hepatic decompensation Evidence of | Ascites | Hepatic Encephalopathy | Bleeding varices | Liver carcinoma
Item
evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
boolean
C1394798 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C2239176 (UMLS CUI [5])
HIV coinfection | HBV coinfection | Hepatitis B Surface Antigens Presence
Item
co-infection with human immunodeficiency virus (hiv) or active hepatitis b virus (hbv) (as determined by presence of hepatitis b surface antigen (hbsag)
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C0019168 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
pegylated interferon alfa | Ribavirin
Item
have received pegylated interferon and/or ribavirin within the 60 days prior to randomization
boolean
C0907160 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance
Item
any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant female or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])