Hepatitis B, Chronic | Therapy naive | Initiation HBV Antiviral Therapy | entecavir | Tenofovir
Item
the subject is chronically infected with hbv.the subject is treatment naïve and is initiating hbv antiviral therapy with either entecavir or tenofovir as indicated in the fda approved label
boolean
C0524909 (UMLS CUI [1])
C0919936 (UMLS CUI [2])
C1704686 (UMLS CUI [3,1])
C0019169 (UMLS CUI [3,2])
C0280274 (UMLS CUI [3,3])
C0971023 (UMLS CUI [4])
C0384228 (UMLS CUI [5])
Therapy naive | Antiviral Therapy Oral | Nucleosides | Nucleotides
Item
the subject will be considered treatment naïve if he/she had <12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0028621 (UMLS CUI [3])
C0028630 (UMLS CUI [4])
Age
Item
the subject is at least 18 years of age at the time of enrollment
boolean
C0001779 (UMLS CUI [1])
Availability of Medical Records | Patient Characteristics | Medical History | Virology | Laboratory Results
Item
adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
boolean
C0470187 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
C0815172 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0205466 (UMLS CUI [4])
C1254595 (UMLS CUI [5])
Informed Consent | Informed Consent Patient Representative
Item
the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Patient Groups
Item
subject is in one of the following patient populations:
boolean
C0030705 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Hepatitis B
Item
acute hbv infection
boolean
C0019163 (UMLS CUI [1])
Hepatitis B Virus Immune Tolerance
Item
patients who are hbv immune tolerant
boolean
C0019169 (UMLS CUI [1,1])
C0020963 (UMLS CUI [1,2])
HIV coinfection | HCV coinfection
Item
human immunodeficiency virus (hiv) and/or hepatitis c virus (hcv) co-infection
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
Solid organ transplant Recipient | Bone Marrow Transplant Recipient
Item
solid organ or bone marrow transplant recipients
boolean
C0730400 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0005961 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Kidney Failure | Dialysis
Item
renal failure or dialysis
boolean
C0035078 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Hepatic decompensation
Item
evidence or history of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Liver carcinoma
Item
evidence or history of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Liver disease | Exception Hepatitis B
Item
underlying liver disease other than hbv
boolean
C0023895 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Chemotherapy | Immunosuppressive Agents
Item
receiving chemotherapy, immunosuppressive agents
boolean
C0392920 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Study Subject Participation Status Inappropriate | Protocol Compliance Unlikely | Medical complication
Item
subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0009566 (UMLS CUI [3])
Study Subject Participation Status | Research study At risk Interference
Item
participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])