Inclusion criteria Quantity Fulfill
Item
subjects must meet one of the following:
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Therapy naive | Antiviral Therapy Absent Hepatitis C | Protocol Arm Roman letter
Item
treatment-naive (subject has never received antiviral treatment for hepatitis c infection) or for arms a, b, and c:
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
C1522541 (UMLS CUI [3,1])
C0439102 (UMLS CUI [3,2])
Therapy Received | Interferon | Ribavirin | Therapy non-responder | Partial responder to therapy | Relapse
Item
treatment experienced (prior null responders, partial responders or relapsers to ifn/rbv)
boolean
C0087111 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
C0919875 (UMLS CUI [4])
C1740822 (UMLS CUI [5])
C0035020 (UMLS CUI [6])
Protocol Arm Roman letter
Item
for arm d:
boolean
C1522541 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Therapy Received | sofosbuvir | PEGINTERFERON | Ribavirin | Breakthrough | Therapy non-responder | Relapse
Item
treatment experienced (prior sofosbuvir (sof) breakthrough/non-responder or prior sof relapser to sof/pegifn/rbv or sof/rbv)
boolean
C0087111 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C2976303 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C3666010 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C0035020 (UMLS CUI [7])
Plasma Hepatitis C virus RNA assay
Item
subject has plasma hcv rna > 1000 iu/ml at screening
boolean
C0032105 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
Chronic Hepatitis C Genotype | Liver Cirrhosis
Item
chronic hcv genotype 4 infection with cirrhosis
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study | Protease Inhibitors | Other Coding | Hepatitis C Virus NS5A Inhibitor | Exposure to ABT-450 | Exposure to Ombitasvir | Investigational New Drugs | DIRECT ACTING ANTIVIRALS
Item
current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or nonstructural viral protein (ns) 5a inhibitor, either investigational or commercially available (including previous exposure to abt-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration. prior use of any direct-acting antiviral will not be allowed, except for arm d where prior experience with the nucleoside polymerase inhibitor, sofosbuvir with pegifn/rbv or sof with rbv is required.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0033607 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C3883357 (UMLS CUI [5])
C0332157 (UMLS CUI [6,1])
C3712108 (UMLS CUI [6,2])
C0332157 (UMLS CUI [7,1])
C3852670 (UMLS CUI [7,2])
C0013230 (UMLS CUI [8])
C3653501 (UMLS CUI [9])
Child-Pugh Classification | Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy.
boolean
C2347612 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
Liver carcinoma
Item
confirmed presence of hepatocellular carcinoma.
boolean
C2239176 (UMLS CUI [1])
Liver disease | Cause Except Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv infection.
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Laboratory test result abnormal
Item
abnormal laboratory tests.
boolean
C0438215 (UMLS CUI [1])