Hepatitis C virus RNA assay Peripheral blood
Item
has hcv rna ≥10,000 iu/ml in peripheral blood at the time of screening
boolean
C1272251 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype
Item
has documented chronic hcv gt1 or gt3 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Liver Cirrhosis Negative Biopsy of liver | Liver Cirrhosis Positive Biopsy of liver | Liver Cirrhosis Negative Fibroscan | Liver Cirrhosis Positive Fibroscan | Liver Cirrhosis Negative Fibrosure | Liver Cirrhosis Positive Fibrosure | Liver Cirrhosis Negative FibroTest Score Measurement | Liver Cirrhosis Positive FibroTest Score Measurement
Item
has either negative or positive history of liver cirrhosis based on liver biopsy, fibroscan, or fibrosure ® (fibrotest®)
boolean
C0023890 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
C0023890 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C4522043 (UMLS CUI [4,3])
C0023890 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C1955263 (UMLS CUI [5,3])
C0023890 (UMLS CUI [6,1])
C1514241 (UMLS CUI [6,2])
C1955263 (UMLS CUI [6,3])
C0023890 (UMLS CUI [7,1])
C1513916 (UMLS CUI [7,2])
C3642160 (UMLS CUI [7,3])
C0023890 (UMLS CUI [8,1])
C1514241 (UMLS CUI [8,2])
C3642160 (UMLS CUI [8,3])
Anti-hepatitis C (HCV) Agents Absent
Item
is treatment naïve to all anti-hcv treatment
boolean
C4324240 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Decompensated liver disease
Item
has evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
HBV coinfection | Hepatitis B surface antigen positive | Human immunodeficiency virus (HIV) coinfection
Item
is coinfected with hepatitis b virus (e.g. hepatitis b surface antigen positive) or human immunodeficiency virus
boolean
C2242656 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Malignant Neoplasms | Evaluation Malignant Neoplasm | Evaluation Malignant Neoplasm Suspected
Item
has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
boolean
C0006826 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
Liver Cirrhosis | Liver carcinoma Imaging of liver | Evaluation Liver carcinoma
Item
has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc
boolean
C0023890 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C2711860 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
Substance Use Disorders
Item
has clinically-relevant drug or alcohol abuse within 12 months of screening
boolean
C0038586 (UMLS CUI [1])
Organ Transplantation | Exception Cornea transplant | Exception Hair transplant | Poor venous access Excludes Peripheral blood Sampling | Operation on stomach | Malabsorption Syndrome | Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1384683 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0191626 (UMLS CUI [3,2])
C0577866 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0229664 (UMLS CUI [4,3])
C0870078 (UMLS CUI [4,4])
C0192398 (UMLS CUI [5])
C0024523 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C3653708 (UMLS CUI [7,3])
Hepatitis, Chronic | Etiology Except Hepatitis C virus
Item
has a history of chronic hepatitis not caused by hcv
boolean
C0019189 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])