Informed Consent
Item
signed patient consent form
boolean
C0021430 (UMLS CUI [1])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA Detectable
Item
genotype 1 chronic hcv with detectable hcv rna
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
Prior Therapy Absent Hepatitis C
Item
no previous treatment for hcv infection
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hepatitis B test negative | HIV negative
Item
hepatitis b and human immunodeficiency virus negative at screening visit
boolean
C1611173 (UMLS CUI [1])
C0481430 (UMLS CUI [2])
Contraceptive methods Willing
Item
able and willing to follow contraception requirements
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Laboratory Results Acceptable | Test Result Acceptable | Physical Examination Acceptable
Item
screening laboratory values, test, and physical exam within acceptable ranges
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0456984 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Body Weight
Item
weight between 40 kg and 125 kg
boolean
C0005910 (UMLS CUI [1])
Use of External Infusion Pump
Item
proficiency in the use of the external pump infusion system
boolean
C1524063 (UMLS CUI [1,1])
C0021437 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
current or planned enrollment in another investigational device or drug study
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Clinic Visits Complete Unable | Protocol Compliance Unable
Item
anticipated inability to complete all clinic visits and comply with study procedures
boolean
C0008952 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medical condition Impact Patient safety
Item
history of, or any current medical condition, which could impact the safety of the subject during the study
boolean
C3843040 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
Hepatitis, Autoimmune | Liver carcinoma Suspected | Decompensated liver disease | Liver disease Except Hepatitis C
Item
autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than hcv
boolean
C0241910 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C4075847 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
alcoholism or substance abuse with <6 documented months of sobriety
boolean
C0001973 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Interferons allergy | Ribavirin allergy
Item
known allergy or sensitivity to interferons or ribavirin
boolean
C0571288 (UMLS CUI [1])
C0571293 (UMLS CUI [2])
Condition Study Subject Participation Status Inappropriate | Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial
Item
any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])