Hepatitis C virus genotype 1 Communicable Disease | HCV viral load Plasma Level
Item
hcv genotype 1 infection and hcv rna plasma level greater than (>) 10,000 international units per milliliter (iu/ml), both determined at screening
boolean
C3532919 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C1868902 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
Protocol Treatment Arm | Fibrosis, Liver Early stage | FibroTest Score Measurement | Aspartate aminotransferase measurement Platelet Count measurement Ratio Index
Item
participants of arm a should have evidence of early stages of liver fibrosis, defined by a fibrosure score less than or equal to (<=) 0.48 and aspartate aminotransferase to platelet ratio index (apri) score <=1
boolean
C1522541 (UMLS CUI [1])
C0239946 (UMLS CUI [2,1])
C2363430 (UMLS CUI [2,2])
C3642160 (UMLS CUI [3])
C0201899 (UMLS CUI [4,1])
C0032181 (UMLS CUI [4,2])
C0456603 (UMLS CUI [4,3])
C0918012 (UMLS CUI [4,4])
Protocol Treatment Arm | Liver Cirrhosis | FibroTest Score Measurement | Aspartate aminotransferase measurement Platelet Count measurement Ratio Index | Biopsy Previous | Metavir score | Esophageal Varices Absent | Grade I esophageal varices | Esophagogastroduodenoscopy | Liver carcinoma Absent | Ultrasonography
Item
participants of arm b should have evidence of cirrhosis, defined by a fibrosure score >0.75 and apri score >2, or a previous (historical) biopsy documenting a metavir score f4. in addition, participants should have absence of esophageal varices or presence of small (grade 1) esophageal varices determined by upper gastrointestinal endoscopy, and absence of findings indicative of hepatocellular carcinoma in an ultrasonography
boolean
C1522541 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C3642160 (UMLS CUI [3])
C0201899 (UMLS CUI [4,1])
C0032181 (UMLS CUI [4,2])
C0456603 (UMLS CUI [4,3])
C0918012 (UMLS CUI [4,4])
C0005558 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C3888527 (UMLS CUI [6])
C0014867 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0940116 (UMLS CUI [8])
C0079304 (UMLS CUI [9])
C2239176 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0041618 (UMLS CUI [11])
Therapy naive Hepatitis C virus | Therapeutic procedure Investigational New Drugs Hepatitis C, Chronic
Item
hcv treatment-naive, defined as not having received treatment with any approved or investigational drug for chronic hcv infection
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
pegylated interferon alfa | Ribavirin | Medical contraindication pegylated interferon alfa Ribavirin
Item
pegylated interferon (pegifn) and ribavirin (rbv) eligible, defined as not having any contraindication to the use of pegifn and rbv, in line with the prescribing information for each compound
boolean
C0907160 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0907160 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Study Main
Item
a. main study:
boolean
C2603343 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
HCV coinfection | Hepatitis C virus genotype | Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | HIV-1 Antibody Measurement Positive | HIV-2 Antibody Measurement Positive
Item
co-infection with hcv of another genotype than genotype 1 and/or human immunodeficiency virus (hiv) type 1 or 2 (positive hiv-1 or hiv 2 antibody test at screening)
boolean
C1698259 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0019704 (UMLS CUI [3,2])
C0275524 (UMLS CUI [4,1])
C0019707 (UMLS CUI [4,2])
C0373916 (UMLS CUI [5,1])
C1446409 (UMLS CUI [5,2])
C0373917 (UMLS CUI [6,1])
C1446409 (UMLS CUI [6,2])
Liver diseases Etiology aspects Hepatitis C virus | Hepatitis A - current infection | Hepatitis B | Hepatitis B surface antigen positive | Liver diseases Due to Substance Use Disorders | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
any evidence of liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a infection, hepatitis b infection (hepatitis b surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0588457 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0038586 (UMLS CUI [5,3])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0221757 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
hepatic; decompensation | grade of esophageal varices
Item
evidence of clinical hepatic decompensation or presence of grade 2/3 esophageal varices
boolean
C1394798 (UMLS CUI [1])
C0940115 (UMLS CUI [2])
LABORATORY ABNORMALITIES
Item
any of the protocol defined laboratory abnormalities
boolean
C1853129 (UMLS CUI [1])
Study Subtype
Item
b. sub-study:
boolean
C2603343 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
Blood Coagulation Disorders | Hemophilia | Hemoglobinopathies | Anemia, Sickle Cell | Thalassemia
Item
presence of coagulopathy (hemophilia) or hemoglobinopathy (including sickle cell disease, thalassemia)
boolean
C0005779 (UMLS CUI [1])
C0684275 (UMLS CUI [2])
C0019045 (UMLS CUI [3])
C0002895 (UMLS CUI [4])
C0039730 (UMLS CUI [5])
Anticoagulants | Warfarin | Heparin | Antiplatelet Agents
Item
use of any anti-coagulant (for example, warfarin, heparin) or anti-platelet medications within 1 week of the screening visit
boolean
C0003280 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0085826 (UMLS CUI [4])
LABORATORY ABNORMALITIES
Item
any of the protocol defined laboratory abnormalities
boolean
C1853129 (UMLS CUI [1])