Age
Item
1. patients who were between 18 and 60, inclusive.
boolean
C0001779 (UMLS CUI [1])
Hepatitis B DNA Measurement
Item
2. patients with hbv dna ³1 x 106 copies/ml within 30 days of baseline.
boolean
C3641250 (UMLS CUI [1])
Hepatitis B surface antigen positive | Laboratory reporting | Hepatitis B e antigen positive | Anti-HBc IgM antibody negative | Anti-HBc IgG antibody positive
Item
3. patients who were documented to be hbsag positive for > 6 months. (the documentation of positive hbsag for the previous 6 months included previous laboratory reports of hbsag positive or hbeag positive at least 6 month ago or igm anti-hbc negative and igg anti-hbc positive at screening).
boolean
C0149709 (UMLS CUI [1])
C0200370 (UMLS CUI [2])
C0392390 (UMLS CUI [3])
C4049511 (UMLS CUI [4])
C1096145 (UMLS CUI [5])
Hepatitis B e antigen positive
Item
4. patients who were hbeag positive.
boolean
C0392390 (UMLS CUI [1])
Alanine aminotransferase measurement | Serum total bilirubin measurement | Prothrombin time | INR | Serum albumin measurement
Item
5. patients with alt levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x uln) and bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), and a serum albumin level of at least 3.5 g/dl.
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
C0523465 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative
Item
6. women of child bearing potential with a negative serum (β-hcg) pregnancy test taken within 14 days of starting therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C1255526 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
7. patients who were 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 | Biological Response Modifier Therapy | Steroid therapy
Item
1. patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
Lamivudine | lobucavir | famciclovir | adefovir | Nucleoside Investigational | Therapeutic procedure Hepatitis B
Item
2. patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for hbv infection.
boolean
C0209738 (UMLS CUI [1])
C0286536 (UMLS CUI [2])
C0209227 (UMLS CUI [3])
C0050175 (UMLS CUI [4])
C0028621 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0019163 (UMLS CUI [6,2])
interferon Ended
Item
3. previous treatment with interferon that had ended less than 6 months prior to the screening visit.
boolean
C0733470 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
4. patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
HCV coinfection | Coinfection HDV | HIV coinfection
Item
5. patients co-infected with hcv, hdv or hiv.
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Liver mass Evidence Clinical | Alpha fetoprotein measurement
Item
6. patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/ml
boolean
C0240225 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0201539 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
7. patients who were pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling | Condoms, Male | Female Sterilization | Hysterectomy | Bilateral tubal ligation | Postmenopausal state | Contraception, Barrier | Intrauterine Devices | Vaginal Spermicides | Sexual Abstinence
Item
8. patients who were unwilling to use an “effective” method of contraception during the treatment and for up to 3 months after cessation of therapy. for males, condoms should be used. females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception ( i.e. iud, barrier methods with spermicide or abstinence)
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
Substance Use Disorders Relevant Clinical
Item
9. patients with a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Gastrointestinal Diseases Significant | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | Gall Bladder Diseases | Cholelithiasis Asymptomatic | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity
Item
10. patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic gb stone, neurological, cardiovascular, oncologic or allergic disease.
boolean
C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C4075847 (UMLS CUI [3])
C1096000 (UMLS CUI [4])
C0016977 (UMLS CUI [5])
C0008350 (UMLS CUI [6,1])
C0231221 (UMLS CUI [6,2])
C0027765 (UMLS CUI [7])
C0007222 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C0020517 (UMLS CUI [10])
Benign Neoplasm Interferes with Continuation Clinical Trial
Item
the patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
boolean
C0086692 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
11. patients with creatinine clearance less than 60ml/min as estimated by the following formula :
boolean
C2711451 (UMLS CUI [1])
Age | Body Weight | Creatinine measurement, serum | Gender
Item
(140-age in years) (body weight [kg]) (72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Hepatitis B virus YMDD mutation DNA Polymerase
Item
patients who were found to have ymdd hbv dna polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. they were to be included in the overall safety evaluation.
boolean
C1717884 (UMLS CUI [1,1])
C0012892 (UMLS CUI [1,2])