DNA Levels
Item
patient with dna levels >=1 x 10^5 copies/ml within 30 days of baseline.
boolean
C0012854 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Hepatitis B surface antigen positive
Item
patient is documented to be hbsag positive for > 6 months.
boolean
C0149709 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
patient has alt levels >=80 iu/l
boolean
C0201836 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test Negative
Item
women of childbearing potential must have a negative urine (β-hcg) pregnancy test taken within 14 days of starting therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Exclusion Criteria
Item
exclusion criteria.
boolean
C0680251 (UMLS CUI [1])
Antiviral Therapy | Immunomodulation | Cytotoxic therapy | Steroid therapy
Item
patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
Interferons
Item
patients previously treated with interferon within the previous 6 months.
boolean
C0021747 (UMLS CUI [1])
Clevudine | Lamivudine | adefovir | entecavir | telbivudine | Nucleosides Investigational | Hepatitis B
Item
patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection.
boolean
C0045212 (UMLS CUI [1])
C0209738 (UMLS CUI [2])
C0050175 (UMLS CUI [3])
C0971023 (UMLS CUI [4])
C1453933 (UMLS CUI [5])
C0028621 (UMLS CUI [6,1])
C1517586 (UMLS CUI [6,2])
C0019163 (UMLS CUI [7])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
patient is coinfected with hcv, hdv or hiv.
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Decompensated liver disease | Liver carcinoma
Item
patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
boolean
C4075847 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Substance Use Disorders
Item
patient has a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Immune System Diseases | Gastrointestinal Diseases | Kidney Diseases | Hematological Disease | Mental disorders | Bronchopulmonary disease | Biliary System Disorder | Cholelithiasis Asymptomatic | nervous system disorder | Heart Diseases | Malignant Neoplasms | Liver carcinoma | Hypersensitivity | Illness Interferes with Therapeutic procedure
Item
patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
boolean
C0021053 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C1096000 (UMLS CUI [6])
C3275124 (UMLS CUI [7])
C0008350 (UMLS CUI [8,1])
C0231221 (UMLS CUI [8,2])
C0027765 (UMLS CUI [9])
C0018799 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C2239176 (UMLS CUI [12])
C0020517 (UMLS CUI [13])
C0221423 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0087111 (UMLS CUI [14,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
boolean
C2711451 (UMLS CUI [1])