Age
Item
1. patient is between 18 and 60, inclusive.
boolean
C0001779 (UMLS CUI [1])
Hbv DNA Positive | Hepatitis B DNA Measurement
Item
2. patient is hbv dna positive with dna levels at screening >= 3 x 1,000,000 copies/ml.
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 hbeag positive.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
4. patient has ast and alt levels which are >= 1 times and <= 10 times the upper limit of normal (x uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement | Gilbert Disease | Bilirubin conjugated normal
Item
5. patient has bilirubin levels <= 1.5 x uln or bilirubin levels > 1.5 x uln with diagnosis of gilbert's disease and conjugated bilirubin within normal limits.
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C0855626 (UMLS CUI [3])
Childbearing Potential Urine pregnancy test Negative
Item
6. women of childbearing age must have a negative urine (b-hcg) pregnancy test before start of trial treatment.
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 | Biological Response Modifiers | Adrenal Cortex Hormones
Item
1. patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Lamivudine | lobucavir | adefovir | famciclovir | Nucleoside Investigational | Hepatitis B
Item
2. patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for hbv infection.
boolean
C0209738 (UMLS CUI [1])
C0286536 (UMLS CUI [2])
C0050175 (UMLS CUI [3])
C0209227 (UMLS CUI [4])
C0028621 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0019163 (UMLS CUI [6])
Interferon To be stopped
Item
3. previous treatment with interferon must have ended at least 6 months prior to the screening visit.
boolean
C0021747 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
4. 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 | HIV coinfection
Item
5. patient is co-infected with hcv or hiv.
boolean
C1698259 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Decompensated cirrhosis Evidence of | Liver carcinoma | Alpha one fetoprotein measurement
Item
6. patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
boolean
C1619727 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2])
C0201539 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
7. patient is 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. 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. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a 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
Item
9. patient has a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Gastrointestinal Diseases | Kidney Diseases | Decompensated liver disease | Bronchopulmonary disease | nervous system disorder | Cardiovascular Diseases | Malignant Neoplasms | Hypersensitivity
Item
10. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
boolean
C0017178 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C4075847 (UMLS CUI [3])
C1096000 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0020517 (UMLS CUI [8])
Study Subject Participation Status | Investigational New Drugs
Item
11. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pharmaceutical Preparation Traditional Chinese Medicine
Item
12. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening visit.
boolean
C0013227 (UMLS CUI [1,1])
C0025124 (UMLS CUI [1,2])
Criteria Protocol Compliance Unable
Item
13. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
boolean
C0243161 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])