Adult | Age | Chronic Hepatitis B | Hepatitis B e antigen positive | Hepatitis B e Antigens Negative
Item
adult subjects (18-75 years of age) with either hepatitis e antigen (hbeag) positive or hbeag negative chronic hbv prior to transplant
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0392390 (UMLS CUI [4])
C0019167 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
Informed Consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Antibody Hepatitis B Surface Antigen Detectable Laboratory Results
Item
subjects with detectable antibody to hepatitis b surface antigen performed by a local laboratory result within 30 days of screening
boolean
C0518943 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
Study Subject Stable status | Decompensated liver disease | Laboratory Parameters Quantity Absent | Bilirubin conjugated increased | Prothrombin time increased | Platelet Count measurement | Serum albumin measurement
Item
subjects must have been stable and may not have had 2 or more of the following laboratory parameters associated with decompensated liver disease: conjugated bilirubin > 1.5 x the upper limit of the normal range (uln), prothrombin time > 1.5 x uln, platelets < 60,000/mm^3, serum albumin < 3.0 g/dl
boolean
C0681850 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])
C0022877 (UMLS CUI [3,1])
C0449381 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0855625 (UMLS CUI [4])
C0151872 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0523465 (UMLS CUI [7])
Prophylactic treatment | Hepatitis B immune globulin
Item
must have had at least 12 weeks of center-specific prophylactic therapy including hepatitis b immunoglobulin (hbig) posttransplant
boolean
C0199176 (UMLS CUI [1])
C0062525 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance ≥ 40 ml/min using the cockcroft-gault equation
boolean
C2711451 (UMLS CUI [1])
Renal function | Deterioration Absent
Item
no significant evidence of ongoing deterioration of renal function
boolean
C0232804 (UMLS CUI [1])
C0868945 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
negative serum beta-human chorionic gonadotropin (for females of childbearing potential only)
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Hepatitis B Recurrence | Hepatitis B DNA Measurement | Transplantation of liver Status post
Item
subjects with hbv recurrence, ie, confirmed hbv dna ≥ 400 copies/ml, following liver transplant
boolean
C0019163 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
C0023911 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant women, women who were breast feeding or who believed they may have wished to become pregnant during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Reproductive potential Contraceptive methods Unwilling
Item
males and females of reproductive potential who were unwilling to use an effective method of contraception during the study and for at least 30 days from the date of last dose of study drug
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Liver carcinoma | Alpha fetoprotein measurement | Standard of Care Measures | Liver carcinoma Multifocal | Transplantation
Item
evidence of hepatocellular carcinoma (hcc), eg, alpha-fetoprotein > 50 ng/ml, or by any other standard of care measure or presence of multifocal hcc at the time of transplantation if transplantation was within 144 weeks of screening
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C2936643 (UMLS CUI [3,1])
C0079809 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0205292 (UMLS CUI [4,2])
C0040732 (UMLS CUI [5])
Tenofovir disoproxil fumarate | emtricitabine
Item
prior tdf or ftc/tdf experience post-transplant or > 12 months treatment with tdf or ftc/tdf treatment pretransplant
boolean
C1099776 (UMLS CUI [1])
C0909839 (UMLS CUI [2])
HCV coinfection Serology | HIV coinfection | HDV Coinfection
Item
coinfection with hepatitis c virus (by serology), hiv, or hepatitis d virus pretransplant or at screening
boolean
C1698259 (UMLS CUI [1,1])
C0220911 (UMLS CUI [1,2])
C4062778 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Kidney Diseases | Cardiovascular Diseases | Lung diseases | nervous system disorder
Item
significant renal, cardiovascular, pulmonary, or neurological disease
boolean
C0022658 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Metabolite | Hypersensitivity Pharmaceutical Excipient
Item
known hypersensitivity to the study drugs, the metabolites, or formulation excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0870883 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Pharmaceutical Preparations Systemic | Effect Nephrotoxic | Immunosuppressive Agents | Cyclosporine | Tacrolimus
Item
were likely to receive systemic drugs with nephrotoxic potential, except immunosuppressive agents (eg, cyclosporine, tacrolimus), during the course of the study
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1280500 (UMLS CUI [2,1])
C1514118 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0085149 (UMLS CUI [5])
Bleeding varices | Hepatic Encephalopathy | Orthotopic liver transplant
Item
history of variceal bleeding or hepatic encephalopathy following orthotopic liver transplantation
boolean
C0333106 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0400447 (UMLS CUI [3])