Chronic Hepatitis C Genotype
Item
previously documented chc genotype 1 infection. other or mixed genotypes are not eligible.
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Biopsy of liver | Histology Consistent with Chronic Hepatitis C
Item
liver biopsy with histology consistent with chc and no other etiology.
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study | Absence Liver findings Suspicious Liver carcinoma
Item
participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma
boolean
C0023890 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0426686 (UMLS CUI [3,2])
C0750493 (UMLS CUI [3,3])
C2239176 (UMLS CUI [3,4])
Prior Therapy failed | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin
Item
failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus rbv
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0796545 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Body Weight
Item
weight between 40 kg and 125 kg, inclusive
boolean
C0005910 (UMLS CUI [1])
Ancestors Local
Item
of 'local' ancestral descent
boolean
C0870134 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods
Item
sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Interferon To be stopped | Ribavirin To be stopped | Adverse event Relationship Ribavirin | Adverse event Relationship Interferon
Item
required discontinuation of previous interferon or rbv regimen for an adverse event considered to be possibly or probably related to rbv and/or interferon
boolean
C3652465 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C0877248 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3652465 (UMLS CUI [4,3])
Ribavirin Recent | Interferon-alpha Recent
Item
treatment with rbv within 90 days and any interferon-alpha within 1 month prior to screening
boolean
C0035525 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0002199 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Therapeutic procedure Hepatitis C | Investigational New Drugs | Herbal medicine Associated with Hepatotoxicity
Item
treatment for hepatitis c with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C2240391 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0235378 (UMLS CUI [3,3])
Investigational New Drugs | Study Subject Participation Status | Interventional Study
Item
treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Diabetes | Hypertensive disease | On examination - eye findings Clinical Significance
Item
diabetes and/or hypertension with clinically significant ocular examination findings
boolean
C0011847 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0437530 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial
Item
any condition the could interfere with participation in and completion of the trial
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Malignant Neoplasms | Malignant Neoplasm Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated
Item
evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])