Age
Item
1. patient is between 18~60 years
boolean
C0001779 (UMLS CUI [1])
Hbv DNA Test Positive | Hepatitis B DNA Measurement
Item
2. patient is hbv dna positive with dna levels ≥ 5 x 10^5 copies/ml within 30 days of baseline.
boolean
C1256114 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
3. patient is documented to be hbsag positive for > 6 months and patient is hbeag positive.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Alanine aminotransferase measurement | Prothrombin time international normalized ratio (PT-INR) | Serum albumin measurement
Item
4. patient has alt levels >=80iu/l, prothrombin time(inr)<1.7 and a serum albumin level of at least 3.5 g/dl.
boolean
C0201836 (UMLS CUI [1])
C1821762 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
Hemoglobin measurement | Gender
Item
5. patient has hemoglobin levels >=11.5g/dl(if woman) or >=12.5g/dl(if man)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Childbearing Potential Urine pregnancy test Negative
Item
6. women of childbearing potential must have a negative urine pregnancy test(β-hcg) taken within 14 days of starting therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
7. patient is able to give written informed consent prior to study start and to comply with the study requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Antiviral Therapy | Immunomodulation | Cytotoxic Chemotherapy | Steroid therapy
Item
1. 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])
Interferon | pegylated interferon alfa | Clevudine | Lamivudine | adefovir | entecavir | telbivudine | Tenofovir | Nucleoside Investigational Hepatitis B
Item
2. patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for hbv infection.
boolean
C3652465 (UMLS CUI [1])
C0907160 (UMLS CUI [2])
C0045212 (UMLS CUI [3])
C0209738 (UMLS CUI [4])
C0050175 (UMLS CUI [5])
C0971023 (UMLS CUI [6])
C1453933 (UMLS CUI [7])
C0384228 (UMLS CUI [8])
C0028621 (UMLS CUI [9,1])
C1517586 (UMLS CUI [9,2])
C0019163 (UMLS CUI [9,3])
HCV coinfection | HIV coinfection
Item
3. patient is coinfected with hcv or hiv.
boolean
C1698259 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Decompensated liver disease | Liver carcinoma
Item
4. patient with clinical evidence of decompensated liver disease or hcc
boolean
C4075847 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
White Blood Cell Count procedure
Item
5. patient has wbc levels < 3.0x10^9/l
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
6. patient has platelets levels < 90x10^9/l
boolean
C0032181 (UMLS CUI [1])
Alpha one fetoprotein measurement
Item
7. patient has alpha fetoprotein levels > 100ng/ml
boolean
C0201539 (UMLS CUI [1])
Thyroid Disease
Item
8. patient has a history of thyroid disease.
boolean
C0040128 (UMLS CUI [1])
Hepatitis, Autoimmune
Item
9. patient has a history of autoimmune hepatitis.
boolean
C0241910 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
10. patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
11. 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
12. 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 | Gall Bladder Diseases | Exception Cholecystolithiasis Asymptomatic | Nervous system disorder | Heart Diseases | Disease Oncologic | Hypersensitivity | Illness Interferes with Therapeutic procedure | Benign Neoplasm Interferes with Completion of clinical trial
Item
13. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. the patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
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])
C0016977 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0947622 (UMLS CUI [8,2])
C0231221 (UMLS CUI [8,3])
C0027765 (UMLS CUI [9])
C0018799 (UMLS CUI [10])
C0012634 (UMLS CUI [11,1])
C0205478 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12])
C0221423 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C0087111 (UMLS CUI [13,3])
C0086692 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C2732579 (UMLS CUI [14,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
14. 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])