Body Weight
Item
weight ≥ 40 kg to ≤ 125 kg
boolean
C0005910 (UMLS CUI [1])
Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods
Item
sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form 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])
Chronic Hepatitis C Genotype
Item
must have documented chronic hepatitis c genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Prior Therapy failed | Interferon Plus Ribavirin
Item
must have failed prior treatment with interferon plus ribavirin
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
Treatment completed | Interferon Plus Ribavirin
Item
must have completed treatment with interferon plus ribavirin for at least 12 weeks
boolean
C0580352 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
Status Cirrhotic Biopsy of liver | Status Non-cirrhotic Biopsy of liver | Status Cirrhotic Fibroscan | Status Non-cirrhotic Fibroscan
Item
must have had a liver biopsy or fibroscan to determine status as cirrhotic or non-cirrhotic
boolean
C0449438 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0449438 (UMLS CUI [2,1])
C0439687 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0449438 (UMLS CUI [3,1])
C0439686 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
C0449438 (UMLS CUI [4,1])
C0439687 (UMLS CUI [4,2])
C4522043 (UMLS CUI [4,3])
Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study
Item
participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the screening visit
boolean
C0023890 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
HIV Coinfection | HBV coinfection
Item
known co-infection with the human immunodeficiency virus (hiv) or the hepatitis b virus
boolean
C4505456 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Treatment Discontinuation Due to Adverse event | Interferon | Ribavirin
Item
prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
boolean
C0087111 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Ribavirin | Interferon
Item
treatment with ribavirin within 90 days and any interferon within 1 month of the screening visit
boolean
C0035525 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
Investigational New Drugs
Item
treatment with any investigational drug within 30 days prior to the screening visit
boolean
C0013230 (UMLS CUI [1])
Midazolam | Pimozide | Amiodarone | Flecainide | Propafenone | Quinidine | Ergot Derivatives
Item
treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the day 1 visit
boolean
C0026056 (UMLS CUI [1])
C0031935 (UMLS CUI [2])
C0002598 (UMLS CUI [3])
C0016229 (UMLS CUI [4])
C0033429 (UMLS CUI [5])
C0034414 (UMLS CUI [6])
C3536994 (UMLS CUI [7])
Study Subject Participation Status | Clinical Trial Investigational
Item
participation in any investigational trial within 30 days of the screening visit
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Child-Pugh Classification
Item
child pugh score > 6 (class b and c)
boolean
C2347612 (UMLS CUI [1])
Study Subject Diabetic | Study Subject Hypertensive | Examination finding Ocular Clinical Significance
Item
diabetic and/or hypertensive participants with clinically significant ocular examination findings
boolean
C0681850 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0857121 (UMLS CUI [2,2])
C0438105 (UMLS CUI [3,1])
C1299003 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
Mental condition Pre-existing
Item
pre-existing psychiatric conditions
boolean
C3840291 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
clinical diagnosis of substance abuse
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms Suspected
Item
active or suspected malignancy
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])