Body Weight
Item
weight between 40 kg and 125 kg
boolean
C0005910 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
documented chc genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Prior Therapy Standard of Care | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin | Response Lacking
Item
previous course of treatment with soc (pegifn-2a or pegifn-2b + rbv) with a documented non-response
boolean
C1514463 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0796545 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C1704632 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Liver Cirrhosis
Item
documented diagnosis of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Liver carcinoma Absent Ultrasonography
Item
no evidence of hepatocellular carcinoma (hcc) by ultrasound
boolean
C2239176 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Study Subject Contraceptive Agents Quantity | Partner Contraceptive Agents Quantity
Item
participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)
boolean
C0681850 (UMLS CUI [1,1])
C0009871 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0009871 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
HIV coinfection | HBV coinfection
Item
co-infection with human immunodeficiency virus (hiv) or hepatitis b virus
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Investigational New Drugs
Item
use of any investigational drugs within 30 days prior to study enrollment
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial | Intention Participation Clinical Trial
Item
participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C1283828 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
Decompensated liver disease | Ascites | Hepatic Encephalopathy | Esophageal Varices Large Grade | Esophageal Varices Esophagogastroduodenoscopy
Item
evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. only participants with large (f3) esophageal varices, as determined in an esophagogastroduodenoscopy (egd) performed within the past 12 months according to international guidelines will be excluded.
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0014867 (UMLS CUI [4,1])
C0549177 (UMLS CUI [4,2])
C0441800 (UMLS CUI [4,3])
C0014867 (UMLS CUI [5,1])
C0079304 (UMLS CUI [5,2])
On examination - eye findings Clinical Significance
Item
clinically significant ocular examination findings
boolean
C0437530 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Psychiatric problems Pre-existing
Item
pre-existing significant psychiatric condition(s)
boolean
C1306597 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
clinical diagnosis of active or recent substance abuse
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated
Item
evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])