Hepatitis C virus RNA assay | Branched Chain 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
C1272251 (UMLS CUI [1])
C1553156 (UMLS CUI [2,1])
C1510438 (UMLS CUI [2,2])
Hepatitis C Genotype
Item
infection with genotype 1 hcv
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy non-responder | Antiviral Response Early failed | Hepatitis C virus RNA assay | Hepatitis C RNA positive Post PEGINTERFERON/RIBAVIRIN
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
C0919875 (UMLS CUI [1])
C1155328 (UMLS CUI [2,1])
C1279919 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C1272251 (UMLS CUI [3])
C0855842 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1875630 (UMLS CUI [4,3])
Laboratory Results Adequate
Item
adequate laboratory parameters
boolean
C1254595 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Quantity | Female Sterilization | Postmenopausal state
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])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Gender Sexually active Contraceptive methods
Item
sexually active male subjects are practicing acceptable methods of contraception during trial participation
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (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])
Self Administration Subcutaneous Injections Daily | Caregiver Subcutaneous Injections 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
C0036589 (UMLS CUI [1,1])
C0021499 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0021499 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
Liver Cirrhosis
Item
clinical, laboratory, or histological evidence of liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
Hepatic decompensation | 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])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C2239176 (UMLS CUI [5])
HIV coinfection | HBV coinfection | Hepatitis B Surface Antigens Present
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])
PEGINTERFERON Recent | Ribavirin Recent
Item
have received pegylated interferon and/or ribavirin within the 60 days prior to enrollment
boolean
C0982327 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Completion of clinical trial
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])
C2732579 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant female or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])