Hepatitis B, Chronic | Anti-HBs antibody Detectable | Hepatitis B Surface Antigens Detectable | Antibody to hepatitis B core antigen IgM type Negative
Item
chronic infection with hepatitis b virus (hbv)(detectable hepatitis b surface antibody (hbsag) at screening and at least 24 weeks prior to screening, or detectable hbsag for <24 weeks and negative for immunoglobulin m core antibody)
boolean
C0524909 (UMLS CUI [1])
C0201478 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C0312632 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
documentation of hepatitis b e antigen (hbeag) positive or negative status
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Nucleoside Analogs naive | Nucleotide analog naive | Exception Adefovir
Item
naive to nucleoside/nucleotide analogues, with the exception of adefovir
boolean
C1579410 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0597107 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0050175 (UMLS CUI [3,2])
Response Suboptimal Adefovir
Item
suboptimal response to adefovir treatment
boolean
C1704632 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
C0050175 (UMLS CUI [1,3])
Lamivudine Resistance Substitution Absent | Telbivudine Resistance Substitution Absent | Entecavir Resistance Substitution Absent | Adefovir Resistance Substitution Absent
Item
no lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
boolean
C0209738 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C1706204 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C1453933 (UMLS CUI [2,1])
C1514892 (UMLS CUI [2,2])
C1706204 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0971023 (UMLS CUI [3,1])
C1514892 (UMLS CUI [3,2])
C1706204 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0050175 (UMLS CUI [4,1])
C1514892 (UMLS CUI [4,2])
C1706204 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Age
Item
male or female gender, aged 16 years and older
boolean
C0001779 (UMLS CUI [1])
Liver function Compensated
Item
compensated liver function
boolean
C0232741 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
Serum alanine aminotransferase measurement
Item
serum alanine aminotransferase level <10*upper limit of normal at screening
boolean
C1883008 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Decompensated cirrhosis
Item
evidence of decompensated cirrhosis
boolean
C1619727 (UMLS CUI [1])
HIV coinfection | HCV coinfection | HDV Coinfection
Item
coinfection with hiv, hepatitis c virus, or hepatitis d virus
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Pancreatitis
Item
recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
boolean
C0030305 (UMLS CUI [1])
Chronic Kidney Insufficiency | Creatinine clearance measurement
Item
chronic renal insufficiency, defined as a creatinine clearance <50 ml/min
boolean
C0403447 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
DRUG ABUSE ILLICIT Preventing Protocol Compliance | Alcohol abuse Preventing Protocol Compliance | DRUG ABUSE ILLICIT At risk Hepatotoxicity | Alcohol abuse At risk Hepatotoxicity | DRUG ABUSE ILLICIT At risk Pancreatitis | Alcohol abuse At risk Pancreatitis
Item
current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
boolean
C0743253 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085762 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0743253 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0235378 (UMLS CUI [3,3])
C0085762 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0235378 (UMLS CUI [4,3])
C0743253 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0030305 (UMLS CUI [5,3])
C0085762 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0030305 (UMLS CUI [6,3])
Medical condition Excludes Completion of clinical trial | Medical condition Requirement Illicit medication use chronic
Item
other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0281875 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
Creatinine measurement, serum | Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count | Alpha-1-fetoprotein measurement, serum
Item
serum creatinine level >1.5 mg/dl; hemoglobin level <10.0 g/dl; platelet count <70,000/mm^3; absolute neutrophil count <1500 cells/mm^3; serum alpha fetoprotein level >100 ng/ml
boolean
C0201976 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0373538 (UMLS CUI [5])
Exception Adefovir | Nucleoside Analogs Previous Against Hepatitis B | Nucleotide analog Previous Against Hepatitis B | Lamivudine | Entecavir | Anti-HBV Antivirals | TCM Preparations
Item
except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b (eg, lamivudine, entecavir), or any other experimental anti-hbv antiviral, or any china traditional medicine
boolean
C1705847 (UMLS CUI [1,1])
C0050175 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0019163 (UMLS CUI [2,4])
C0597107 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0521124 (UMLS CUI [3,3])
C0019163 (UMLS CUI [3,4])
C0209738 (UMLS CUI [4])
C0971023 (UMLS CUI [5])
C4020577 (UMLS CUI [6,1])
C0003451 (UMLS CUI [6,2])
C0025124 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
Interferon | alpha-Thymosin | Immunostimulants
Item
therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
boolean
C3652465 (UMLS CUI [1])
C0368651 (UMLS CUI [2])
C0001551 (UMLS CUI [3])
Requirement Immunosuppressive Agents chronic | High risk of Nephrotoxicity | High risk of Hepatotoxicity | Immunosuppressive Agents chronic Affecting Renal Elimination
Item
required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
boolean
C1514873 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0332167 (UMLS CUI [2,1])
C0599918 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0235378 (UMLS CUI [3,2])
C0021081 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C1373187 (UMLS CUI [4,4])