Informed Consent
Item
participant has provided written consent.
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Female Sterilization
Item
if female, participant is postmenopausal or surgically sterile.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Gender | Contraceptive methods Quantity
Item
if male, must be practicing two effective methods of birth control.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hepatitis C virus genotype 1 | Hepatitis C virus RNA assay
Item
participant is hepatitis c virus (hcv) genotype 1 with hcv ribonucleic acid levels >50,000 iu/ml.
boolean
C3532919 (UMLS CUI [1])
C1272251 (UMLS CUI [2])
Chronic Hepatitis C disease length
Item
participants must demonstrate chronic hepatitis c infection for at least 6 months prior to study enrollment.
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Biopsy of liver | Histology Consistent with Hepatitis C | Absence Liver Cirrhosis Due to Cause Other | Absence Liver disease Due to Cause Other
Item
participants must have a liver biopsy with histology consistent with hcv-induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv.
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0023890 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0015127 (UMLS CUI [3,4])
C0205394 (UMLS CUI [3,5])
C0332197 (UMLS CUI [4,1])
C0023895 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0015127 (UMLS CUI [4,4])
C0205394 (UMLS CUI [4,5])
General health good | Exception Hepatitis C
Item
condition of general good health other then hcv infection.
boolean
C1277245 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Thyroid Disease Serum TSH level normal
Item
participants with a history of thyroid disease must have a thyroid stimulating hormone (tsh) value in the normal range.
boolean
C0040128 (UMLS CUI [1,1])
C0580433 (UMLS CUI [1,2])
Therapeutic procedure Absent Hepatitis C
Item
no prior history of receiving therapy for hcv infection.
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hepatitis A IgM Positive | Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag), or human immunodeficiency virus antibody (hiv ab).
boolean
C0856422 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
Pregnancy | Breast Feeding | Partner Pregnant Women
Item
pregnant or breastfeeding females or male partners of women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0682323 (UMLS CUI [3,1])
C0033011 (UMLS CUI [3,2])
Seizures | Malignant Neoplasms
Item
history of seizures or cancer.
boolean
C0036572 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Major Depressive Disorder
Item
history of major depressive disorder within 2 years.
boolean
C1269683 (UMLS CUI [1])
Liver Cirrhosis
Item
any current or past history of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Cause Any Liver disease | Exception Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv infection.
boolean
C0015127 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])