Chronic Hepatitis C Genotype
Item
subjects chronically infected with hcv genotype 1
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Compensated cirrhosis
Item
subjects with compensated cirrhosis
boolean
C1608426 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Study Subjects Therapy naive | Interferon Absent | Interferon-alpha Absent | Peginterferon alfa-2a Absent | Peginterferon alfa-2b Absent | Ribavirin Absent | HCV DIRECT ACTING ANTIVIRALS Absent | Protease Inhibitors Absent | RNA dependent RNA Polymerase Inhibitors Absent
Item
treatment-naïve subjects with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv), or hcv direct acting antivirals (daa) (protease, polymerase inhibitor, etc.)
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002199 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0391001 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0796545 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0035525 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0220847 (UMLS CUI [7,1])
C3653501 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C0033607 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C3883351 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Study Subjects Therapy Experience | Anti-hepatitis C (HCV) Agents | Exception Daclatasvir | Exception Asunaprevir | Exception BMS-791325 | Nucleoside inhibitor | Nucleotide inhibitors | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor | Cyclophilin inhibitors | MicroRNA inhibitors
Item
treatment-experienced subjects are eligible including exposure to anti-hcv agents of a mechanistic class other than those contained in the daclatasvir (dcv) / asunaprevir (asv) /bms-791325 triple regimen is permitted. examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5b (ns5b) polymerase, inhibitors of cyclophilin, or inhibitors of microrna.
boolean
C0681850 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0596545 (UMLS CUI [1,3])
C4324240 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C3252090 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C3491974 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C3852614 (UMLS CUI [5,2])
C0597104 (UMLS CUI [6])
C0028630 (UMLS CUI [7,1])
C0243077 (UMLS CUI [7,2])
C4020255 (UMLS CUI [8])
C0917877 (UMLS CUI [9,1])
C0243077 (UMLS CUI [9,2])
C1101610 (UMLS CUI [10,1])
C0243077 (UMLS CUI [10,2])
Liver Cirrhosis Absent
Item
subjects without cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Transplantation of liver | Organ Transplantation
Item
liver or any other organ transplant
boolean
C0023911 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Malignant Neoplasms
Item
current or known history of cancer within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
Liver carcinoma | Liver carcinoma Suspected
Item
documented or suspected hepatocellular carcinoma(hcc)
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Decompensated liver disease Radiology | 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 [1,1])
C0043299 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])