Medical History Consistent with Chronic Hepatitis B Compensated
Item
clinical history compatible with compensated chronic hepatitis b
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
C0205432 (UMLS CUI [1,4])
Chronic Hepatitis B Compensated
Item
documented compensated chronic hepatitis b defined by the following:
boolean
C0524909 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Serum Hepatitis B Surface Antigen Test Positive | Hepatitis B surface antigen positive Quantity | Hepatitis B e antigen positive | Signs Disease | Hepatitis B DNA Measurement | Alanine aminotransferase increased Quantity | Hepatitis B e antigen negative
Item
opositive serum hbsag at screening and at least one other documentation of hbsag positive at least 6 months prior to screening ofor hbeag positive patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 5 log10 copies/ml (or 20 000 iu/ml) (cobas taqman®) at screening ; serum alt ≥ 1.5×uln and < 10×uln (pediatric uln) for two times during the screening period or within 6 months prior to screening ofor hbeag negative patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 4 log10 copies/ml (or 2 000 iu/ml) (cobas taqman®) at screening) ; serum alt ≥ 1.0 ×uln and < 10×uln (pediatric uln) for two times during the screening period or within 12 months prior to screening)
boolean
C1254699 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0392390 (UMLS CUI [3])
C0311392 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C3641250 (UMLS CUI [5])
C0151905 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0948827 (UMLS CUI [7])
Hepatitis C | Hepatitis C, Chronic | Hepatitis D Infection | Hepatitis D, Chronic | HIV Infection | Chronic infection with HIV | Hepatitis A | Hepatitis E | Cytomegalovirus Infections | Epstein-Barr Virus Infections | Herpes Simplex Virus Infection
Item
patients with acute or chronic infection of hcv, hdv, hiv, or with acute infection of hav, hev, cmv, ebv, or hsv.
boolean
C0019196 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0524911 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
C0853112 (UMLS CUI [6])
C0019159 (UMLS CUI [7])
C0085293 (UMLS CUI [8])
C0010823 (UMLS CUI [9])
C0149678 (UMLS CUI [10])
C0019348 (UMLS CUI [11])
Interferon | Biological Response Modifiers | Nucleosides | Nucleotides | Therapeutic procedure Against Chronic Hepatitis B
Item
patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-chb treatment (approved or investigational) at any time before screening
boolean
C3652465 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0028621 (UMLS CUI [3])
C0028630 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0521124 (UMLS CUI [5,2])
C0524909 (UMLS CUI [5,3])
Patient need for Acyclovir Systemic | Patient need for Famciclovir | Patient need for CORTICOSTEROIDS SYSTEMIC | Patient need for Pharmaceutical Preparations Hepatotoxic effect | Patient need for Pharmaceutical Preparations Nephrotoxic | Patient need for Chemotherapy
Item
patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
boolean
C0686904 (UMLS CUI [1,1])
C0001367 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0209227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C3653708 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0235378 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1514118 (UMLS CUI [5,3])
C0686904 (UMLS CUI [6,1])
C0392920 (UMLS CUI [6,2])
Cause Primary Quantity Liver disease | Cause Secondary Quantity Liver disease | Exception Chronic Hepatitis B | Decompensated Liver Disease | Liver transplant recipient | Organ transplant Recipient | Bone marrow transplant recipient
Item
patient has one or more additional known primary or secondary causes of liver disease, other than chb; has a decompensated liver disease ; is a liver transplant recipient or organ or bone marrow transplant recipient.
boolean
C0015127 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0023895 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0023895 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0524909 (UMLS CUI [3,2])
C0745744 (UMLS CUI [4])
C3811922 (UMLS CUI [5])
C0524930 (UMLS CUI [6,1])
C1709854 (UMLS CUI [6,2])
C4545296 (UMLS CUI [7])
Other medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate
Item
history of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Myopathy | Myositis | Muscle Weakness Persistent | High serum creatine kinase Persistent | Muscular disease Any
Item
patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum ck levels (≥7×uln), any muscular disease
boolean
C0026848 (UMLS CUI [1])
C0027121 (UMLS CUI [2])
C0151786 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0241005 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
C0026848 (UMLS CUI [5,1])
C1552551 (UMLS CUI [5,2])
Pharmaceutical Preparations Associated with Myopathy
Item
patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0026848 (UMLS CUI [1,3])
Disease Clinical Significance | Condition Clinical Significance | Abnormality Clinical Significance | Independent of Hepatitis B
Item
any other clinical significant disease, condition or abnormality, unrelated to their hbv infection at screening, as assessed by the investigator
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1704258 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0332291 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])