Hepatitis C Genotype
Item
participant must have hepatitis c virus (hcv) genotype 4 infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
boolean
C1272251 (UMLS CUI [1])
Liver Cirrhosis | Requirement Imaging procedure Hepatic | Ultrasonography | Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Excluded
Item
in participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [ct] scan, or magnetic resonance imaging [mri]) within 6 months before baseline (day 1) to exclude hepatocellular carcinoma is required
boolean
C0023890 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C0205054 (UMLS CUI [2,3])
C0041618 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C2239176 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative
Item
a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on day 1 before first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Contraceptive methods Quantity | Contraception, Barrier | Condom | Vaginal contraceptive diaphragm | Sexually active heterosexual activity Absent | Vasectomy | Gender Partner Vasectomy | Postmenopausal state | Female Sterilization
Item
females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from day 1 (baseline) and continue until 30 days after the end of treatment (eot) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
C0677582 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C4272228 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0042387 (UMLS CUI [8])
C0079399 (UMLS CUI [9,1])
C0682323 (UMLS CUI [9,2])
C0042387 (UMLS CUI [9,3])
C0232970 (UMLS CUI [10])
C0015787 (UMLS CUI [11])
Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Liver disease Independent of Hepatitis C virus | Hepatitis A | Liver disease Drug-induced | Alcohol-related liver disease | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
participant has any liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a, 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])
C0332291 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0019159 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
C0810031 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0019202 (UMLS CUI [7])
C0221757 (UMLS CUI [8])
C3241937 (UMLS CUI [9])
C0008312 (UMLS CUI [10])
Hepatitis C Except Genotype Specified | HCV coinfection Except Genotype Specified
Item
participant is infected/co-infected with non-genotype 4 hcv
boolean
C0019196 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1148363 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C1698259 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1148363 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
Disease Clinical Significance At risk Patient safety | Disease Interferes with Study Subject Participation Status | Disease Interferes with Completion of clinical trial | Signs and Symptoms Clinical Significance | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography
Item
participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ecg) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0037088 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C0022885 (UMLS CUI [7])
C1623258 (UMLS CUI [8])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence
Item
participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C4528387 (UMLS CUI [5,2])
C1458156 (UMLS CUI [5,3])