Chronic infectious disease Hepatitis C virus genotype 1b
Item
participant must have chronic hepatitis c virus (hcv) genotype 1b infection confirmed at screening
boolean
C0151317 (UMLS CUI [1,1])
C3495940 (UMLS CUI [1,2])
HCV viral load
Item
participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
boolean
C1868902 (UMLS CUI [1])
Fibrosis stage | Liver diseases Tumor Stage Classification | Transient elastography | Metavir score | Liver Cirrhosis | Biopsy
Item
participant must have documented fibrosis stage at screening (or between screening and day 1 [baseline]). liver disease will be staged based on one of the following methods. a) shear wave elastography (fibroscan) within less than or equal to (<=) 6 months before screening or between screening and day 1 (baseline). metavir f3 > 9.6 kilopascals (kpa) and the cut-off for cirrhosis is greater than or equal to (>=) 14.6 kpa. b) a biopsy documenting metavir f3-f4. biopsy performed within the 24 months before screening will be accepted for participants with metavir score f3. for cirrhotic participants (metavir score f4) a biopsy performed at any previous time is acceptable
boolean
C1954435 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0178759 (UMLS CUI [2,2])
C2748260 (UMLS CUI [3])
C3888527 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0005558 (UMLS CUI [6])
Liver Cirrhosis | Imaging of liver | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Absent
Item
participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [ct] scan or magnetic resonance imaging [mri]) within 6 months prior to the screening visit (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma
boolean
C0023890 (UMLS CUI [1])
C2711860 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C2239176 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Body mass index
Item
participant must have a body mass index (bmi) >= 18 kilogram per meter^2 (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Therapy naive | Hepatitis C virus | Investigational New Drugs
Item
participant must be treatment naive (that is, have not received prior treatment for hcv with any approved or investigational drug)
boolean
C0919936 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
HCV coinfection | Hepatitis C virus genotype
Item
participant has co-infection with hcv of another genotype; a) participant who has hcv genotype 1b has coinfection with hcv of a genotype other than genotype 1b
boolean
C1698259 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
Hepatitis C virus genotype 1b positive | Genetic variant assessment | Amino Acid Substitution
Item
chronic hcv genotype 1b-infected participant who has the presence of genetic variants coding for the ns5a-y93h and/or l31m/v amino acid substitutions at screening
boolean
C3495940 (UMLS CUI [1])
C3263354 (UMLS CUI [2])
C0525038 (UMLS CUI [3])
hepatic; decompensation Episode | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Chronic liver disease Etiology aspects Hepatitis C virus | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Cholangitis | Liver diseases Due to Substance Use Disorders | Primary biliary cirrhosis
Item
participant has chronic liver disease of a non-hcv etiology (including but not limited to hemochromatosis, wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
boolean
C0341439 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0018995 (UMLS CUI [2])
C0019202 (UMLS CUI [3])
C0221757 (UMLS CUI [4])
C0008311 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0038586 (UMLS CUI [6,3])
C0008312 (UMLS CUI [7])
Disease At risk patient safety | Disease Study Subject Participation Status Compliance behavior Limited
Item
participant has any other uncontrolled clinically significant disease or clinically significant findings during screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
Coinfection Hepatitis A Virus | HBV coinfection | Hepatitis A virus IgM antibody Positive | Hepatitis B surface antigen positive
Item
participant has coinfection with hepatitis a or hepatitis b virus (hepatitis a antibody immunoglobulin m [igm] or hepatitis b surface antigen [hbsag] positive at screening)
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C0369327 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
Solid organ transplant
Item
participant has received a solid organ transplant
boolean
C0730400 (UMLS CUI [1])