Body mass index
Item
participants with body mass index (weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 35.0 kilogram per square meter kg/m^2, extremes included
boolean
C1305855 (UMLS CUI [1])
Therapy naive | Pharmacotherapy Absent
Item
participants must be treatment-naive (that is, have not received prior treatment with any approved or investigational drug)
boolean
C0919936 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hepatitis C virus RNA assay
Item
participants with hcv ribonucleic acid (rna) plasma levels greater than (>) 10,000 international unit per milliliter (iu/ml) and lower than 6,000,000 international unit per milliliter (iu/ml) at screening
boolean
C1272251 (UMLS CUI [1])
Liver Cirrhosis Absent | FibroTest Score Measurement | AST to platelet ratio index | Fibroscan
Item
participants with absence of cirrhosis confirmed by fibrotest/fibrosure score less or equal to 0.75 and an aspartate aminotransferase to platelet ration index less or equal to 2 or a fibroscan less or equal to 14.6 kilopascale (kpa), performed within 6 months prior or during the screening period
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3642160 (UMLS CUI [2])
C4483916 (UMLS CUI [3])
C4522043 (UMLS CUI [4])
Chronic Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C antibody positive | Change Histological Consistent with Chronic Hepatitis | Biopsy of liver
Item
participants with documented chronic hcv infection: diagnosis of hcv infection >6 months prior to screening, either by detectable hcv rna, an hcv positive antibody test or presence of histological changes consistent with chronic hepatitis in a liver biopsy
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0281863 (UMLS CUI [3])
C0392747 (UMLS CUI [4,1])
C0205462 (UMLS CUI [4,2])
C0332290 (UMLS CUI [4,3])
C0019189 (UMLS CUI [4,4])
C0193388 (UMLS CUI [5])
Hepatitis C Genotype | HCV coinfection Genotype | Exception Hepatitis C virus genotype Specified | HIV Infection HIV-1 | HIV Infection HIV-2 | Coinfection HIV-1 | Coinfection HIV-2
Item
participant has infection/co-infection with hcv of a genotype other than genotype 1, human immunodeficiency virus (hiv) type 1 or 2
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
C0019693 (UMLS CUI [4,1])
C0019704 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5,1])
C0019707 (UMLS CUI [5,2])
C0275524 (UMLS CUI [6,1])
C0019704 (UMLS CUI [6,2])
C0275524 (UMLS CUI [7,1])
C0019707 (UMLS CUI [7,2])
Liver diseases | Etiology Absent Hepatitis C virus | Hepatitis A | Drug-Induced Liver Disease | Alcoholic Liver Diseases | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
participant has any evidence of liver disease of non-hcv etiology. this includes, but is not limited to acute hepatitis a, active hepatitis b, 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-hc liver disease considered clinically significant by the investigator
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0019159 (UMLS CUI [3])
C0860207 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0221757 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
Comorbidity compromises Patient safety | Condition compromises Patient safety | Finding compromises Patient safety | Comorbidity Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Finding Interferes with Study Subject Participation Status | Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Finding Interferes with Completion of clinical trial
Item
participant with significant co-morbidities, conditions or clinical significant findings during screening assessments 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
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0243095 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0243095 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0009488 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2732579 (UMLS CUI [8,3])
C0243095 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2732579 (UMLS CUI [9,3])
Organ Transplantation | Exception Keratoplasty | Exception Hair transplant procedure | Exception Skin Transplantation
Item
participant received an organ transplant (other than cornea or hair transplant or skin graft)
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0010042 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0191626 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0037297 (UMLS CUI [4,2])
Laboratory test result abnormal Study Protocol
Item
participants have key protocol defined laboratory abnormalities
boolean
C0438215 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])