Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
positive hbsag >= 6 months prior to randomization and positive hbeag at screening.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Hepatitis B DNA Measurement | Polymerase Chain Reaction
Item
serum hbv dna greater than or equal to 1 x 100,000 copies/ml (pcr assay) at initial or confirmatory screening visit.
boolean
C3641250 (UMLS CUI [1])
C0032520 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
serum alt levels greater than or equal to 1.5 x uln at both initial and confirmatory screening visits.
boolean
C0201836 (UMLS CUI [1])
Compensated liver disease | Continuance of life Anticipated
Item
compensated liver disease with anticipated survival greater than 12 months and with the following laboratory and clinical parameters within 4 weeks of baseline:
boolean
C3839044 (UMLS CUI [1])
C0038952 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Prothrombin time assay | Bilirubin, total measurement | Bilirubin, direct measurement Normal | Serum albumin measurement | Ascites | Bleeding varices | Encephalopathies | Splenomegaly | Renal function | Creatinine clearance measurement Creatinine-based formula (Schwartz)
Item
*prothrombin time less than or equal to 1 second above normal range. *total bilirubin less than 1.3 mg/dl or normal direct bilirubin. *serum albumin greater than 3 g/dl (greater than 30 g/l). *no clinical history of ascites, variceal bleeding, encephalopathy or splenomegaly. *adequate renal function defined as creatinine clearance greater than or equal to 80 ml/min (calculated using schwartz formula).
boolean
C0033707 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201916 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0523465 (UMLS CUI [4])
C0003962 (UMLS CUI [5])
C0333106 (UMLS CUI [6])
C0085584 (UMLS CUI [7])
C0038002 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C0373595 (UMLS CUI [10,1])
C1980037 (UMLS CUI [10,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Immunoglobulins | Interferons | Lamivudine
Item
received immunoglobulin, interferon or lamivudine therapy within 6 months prior to initial screening visit.
boolean
C0021027 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0209738 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
participated in any investigational trial with any investigational compound within 2 months prior to initial screening.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Transplanted organ Recipient | Autologous bone marrow transplant Recipient
Item
organ or bone marrow transplant recipients.
boolean
C0524930 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0194037 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Decompensated liver disease Evidence Clinical
Item
clinical evidence of decompensated liver disease.
boolean
C4075847 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Child-Pugh-Turcotte score
Item
a child-pugh-turcotte score greater than 6.
boolean
C3854424 (UMLS CUI [1])
Protocol Compliance Unable
Item
inability to comply with study requirements.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])