Age | Chronic Hepatitis B HBeAg positive Compensated
Item
male or female, 18-70 years of age with documented compensated hepatitis b "e" antigen (hbeag)-positive chronic hepatitis b
boolean
C0001779 (UMLS CUI [1])
C0524909 (UMLS CUI [2,1])
C0392390 (UMLS CUI [2,2])
C0205432 (UMLS CUI [2,3])
Protocol Compliance | Informed Consent
Item
able to comply with study regimen and provide written informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Barrier Contraception Double Unwilling
Item
unwilling to use double barrier method of contraception
boolean
C0004764 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Therapeutic procedure Hepatitis B
Item
received hepatitis b therapy in the past
boolean
C0087111 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
Immunomodulators
Item
use of immunomodulatory therapy in past 12 months
boolean
C1527392 (UMLS CUI [1])
Hepatic decompensation Symptoms | Pancreatitis Symptoms
Item
history of or symptoms of hepatic decompensation or pancreatitis
boolean
C1394798 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Hepatotoxicity Pharmaceutical Preparations Frequent | Hepatotoxicity Pharmaceutical Preparations Prolonged | Pharmaceutical Preparations Nephrotoxic Frequent | Pharmaceutical Preparations Nephrotoxic Prolonged
Item
frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
boolean
C0235378 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332183 (UMLS CUI [1,3])
C0235378 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1514118 (UMLS CUI [3,2])
C0332183 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C1514118 (UMLS CUI [4,2])
C0439590 (UMLS CUI [4,3])
Pharmaceutical Preparation Excludes Protocol Compliance
Item
concurrent medication likely to preclude compliance with schedule of evaluations
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Investigational New Drugs
Item
use of other investigational drugs within 30 days of enrollment
boolean
C0013230 (UMLS CUI [1])
Laboratory test result abnormal
Item
abnormal laboratory values during screening
boolean
C0438215 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])