Protocol Compliance | Able to communicate Research Personnel
Item
subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
boolean
C0525058 (UMLS CUI [1])
C2364293 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
Chronic Hepatitis C Genotype
Item
subjects chronically infected with hcv genotype 3
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Therapy naive Hepatitis C
Item
subjects who are hcv-treatment-naive
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Therapy Experience Hepatitis C
Item
subjects who are hcv-treatment-experienced
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Exposure to NS5A Inhibitor Illicit
Item
previous exposure to non-structural 5a (ns5a) inhibitors is prohibited
boolean
C0332157 (UMLS CUI [1,1])
C3883357 (UMLS CUI [1,2])
C0332266 (UMLS CUI [1,3])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Hepatitis C virus genotype | Exception Hepatitis C virus genotype Specified | Hepatitis C Genotype Mixed
Item
hcv genotypes other than genotype (gt) -3 infection; mixed genotype infections are not permitted
boolean
C1148363 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1148363 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0019196 (UMLS CUI [3,1])
C0017431 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
Transplantation of liver | Organ Transplantation | Hemopoietic stem cell transplant | Exception Keratoplasty | Exception Hair transplant
Item
liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
boolean
C0023911 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
C0472699 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0010042 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0191626 (UMLS CUI [5,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Liver carcinoma Imaging study | Liver carcinoma Suspected Imaging study | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver
Item
documented or suspected hepatocellular carcinoma (hcc), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
boolean
C2239176 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Decompensated liver disease | Criteria Radiologic | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C0205483 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0019151 (UMLS CUI [5])