Age
Item
1. male or female, 16 to 75 years of age
boolean
C0001779 (UMLS CUI [1])
Compensated liver disease Child-Pugh Classification
Item
2. compensated liver disease(child-pugh class a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Hepatitis B surface antigen positive
Item
3. hbsag positive at least 6 months or more
boolean
C0149709 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
4. hbeag positive or negative
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Lamivudine Resistance | HBV Mutation
Item
5. confirmation of lamivudine-resistance hbv mutation anytime before the study
boolean
C0209738 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C0019169 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
Response Suboptimal | Hepatitis B DNA Measurement | Combined Modality Therapy | Adefovir | Lamivudine | Hepatitis B virus DNA Polymerase Chain Reaction
Item
6. patients with suboptimal response (hbv dna > 2000 iu/ml despite combination of adefovir [10 mg/day] plus lamivudine [100 mg/day] for 6 months or more). serum hbv dna should be determined by the pcr assay at the local laboratory at screening for this study
boolean
C1704632 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0050175 (UMLS CUI [4])
C0209738 (UMLS CUI [5])
C0369332 (UMLS CUI [6,1])
C0032520 (UMLS CUI [6,2])
Patient Ambulatory
Item
7. patient is ambulatory.
boolean
C0030705 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
Protocol Compliance
Item
8. patient is willing and able to comply with the study drug regimen and all other study requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
9. the patient is willing and able to provide written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma | Foci Suspicious Imaging studies | Elevated serum alpha-fetoprotein
Item
1. patient has a history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc, such as suspicious foci on imaging studies or elevated serum alpha fetoprotein (afp) levels. in patients with such findings, hcc should be ruled-out prior to randomizing the patient for the present study.
boolean
C2239176 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0205234 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C1881134 (UMLS CUI [3,3])
C3808572 (UMLS CUI [4])
Antiviral Agents Oral | Exception Lamivudine | Exception Adefovir
Item
2. patient previously received oral antiviral agent other than lamivudine or adefovir
boolean
C0003451 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0050175 (UMLS CUI [3,2])
Interferon therapy Hepatitis B | Immunomodulation Hepatitis B
Item
3. patient has received interferon or other immunomodulatory treatment for hbv infection within 12 months before screening for this study.
boolean
C0279030 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Viral infections chronic | Hepatitis C, Chronic | Chronic infection with HIV
Item
4. patient has concomitant other chronic viral infection (hcv or hiv)
boolean
C0042769 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0524910 (UMLS CUI [2])
C0853112 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum
Item
5. patient has evidence of renal insufficiency defined as serum creatinine > 1.5 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Medical condition Requirement Prednisolone systemic | Medical condition Requirement Immunosuppressive Agents | Medical condition Requirement Chemotherapeutic agent
Item
6. patient has medical condition that requires use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0032950 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0729502 (UMLS CUI [3,3])
Alcohol abuse | DRUG ABUSE ILLICIT
Item
7. patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
boolean
C0085762 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
8. patient is pregnant or breastfeeding or willing to be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Causes Primary Quantity Liver disease | Causes Secondary Quantity Liver disease | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Hepatitis, Autoimmune | Malignant Neoplasms Hepatic Involvement | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Condition Congenital Affecting Liver | Condition Metabolic Affecting Liver | Congestive heart failure | Cor pulmonale Severe
Item
9. patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis b (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.).
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])
C0019163 (UMLS CUI [3,2])
C0001973 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
C0006826 (UMLS CUI [6,1])
C0441932 (UMLS CUI [6,2])
C0018995 (UMLS CUI [7])
C0221757 (UMLS CUI [8])
C0019202 (UMLS CUI [9])
C0348080 (UMLS CUI [10,1])
C1744681 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0023884 (UMLS CUI [10,4])
C0348080 (UMLS CUI [11,1])
C0311400 (UMLS CUI [11,2])
C0392760 (UMLS CUI [11,3])
C0023884 (UMLS CUI [11,4])
C0018802 (UMLS CUI [12])
C0034072 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
Malignant Neoplasms Treated allowed | Exception Liver carcinoma | Malignant Neoplasms In complete remission | Chemotherapy Absent | Surgical intervention Additional Absent
Item
10. a history of treated malignancy (other than hepatocellular carcinoma) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years.
boolean
C0006826 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0677874 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C4035998 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Clinical signs Decompensated liver disease
Item
11. clinical signs of decompensated liver disease as indicated by any one of the following:
boolean
C3540840 (UMLS CUI [1,1])
C4075847 (UMLS CUI [1,2])
Serum bilirubin measurement
Item
serum bilirubin > 3 mg/dl
boolean
C0428441 (UMLS CUI [1])
Prothrombin time increased | International Normalized Ratio
Item
prothrombin time > 6 seconds prolonged or inr >1.6
boolean
C0151872 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum albumin measurement
Item
serum albumin < 2.8 g/dl
boolean
C0523465 (UMLS CUI [1])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
history of ascites, variceal hemorrhage, or hepatic encephalopathy
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
Child-Pugh score
Item
child-pugh score ≥7
boolean
C4050412 (UMLS CUI [1])