Plasma Hepatitis C virus RNA IU/mL
Item
plasma hepatitis c virus (hcv) ribonucleic acid (rna) level greater than 10,000 international unit per milliliter (iu/ml) at screening
boolean
C0032105 (UMLS CUI [1,1])
C0369335 (UMLS CUI [1,2])
C0439458 (UMLS CUI [1,3])
Absence Therapeutic procedure Hepatitis C virus
Item
participant never received treatment for hcv
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
Good health | Exception Hepatitis C | Medical History | Physical Examination | Vital signs | Electrocardiography | Medical condition chronic Under control
Item
participant was to be in good health (besides hcv infection), in the opinion of the investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ecg]), with any chronic medical conditions under stable medical control
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0518766 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C2911690 (UMLS CUI [7,3])
Avoidance Concomitant Agent | Exclusion Criteria | Liver Cirrhosis | Alcohol consumption compromises Patient safety | Barbiturates compromise Patient safety | Amphetamine compromises Patient safety | Narcotic Drugs compromise Patient safety | Alcohol consumption compromises Protocol Compliance | Barbiturates compromise Protocol Compliance | Amphetamine compromises Protocol Compliance | Narcotic Drugs compromise Protocol Compliance
Item
participant had to be willing to refrain from the concomitant use of any medications or substances exclusion criteria: - participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with study procedures
boolean
C0870186 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C0004745 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0002658 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C1113679 (UMLS CUI [6,3])
C0237425 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0001948 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0004745 (UMLS CUI [9,1])
C2945640 (UMLS CUI [9,2])
C0525058 (UMLS CUI [9,3])
C0002658 (UMLS CUI [10,1])
C2945640 (UMLS CUI [10,2])
C0525058 (UMLS CUI [10,3])
C0237425 (UMLS CUI [11,1])
C2945640 (UMLS CUI [11,2])
C0525058 (UMLS CUI [11,3])
HIV coinfection | HBV coinfection
Item
participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned | Breast Feeding | Partner Study participant Pregnancy | Partner Study participant Breast Feeding
Item
female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0682323 (UMLS CUI [4,1])
C0681850 (UMLS CUI [4,2])
C0032961 (UMLS CUI [4,3])
C0682323 (UMLS CUI [5,1])
C0681850 (UMLS CUI [5,2])
C0006147 (UMLS CUI [5,3])
Hypersensitivity Tartrazine
Item
participant has hypersensitivity to tartrazine
boolean
C0020517 (UMLS CUI [1,1])
C0039329 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])