Hepatitis B, Chronic | Biopsy of liver | Hepatitis B DNA Measurement
Item
chronic hepatitis b (confirmed by a liver biopsy performed within 3 years prior to the screenings visit and hbv dna in serum >10e5 copies/ml at the screenings visit).
boolean
C0524909 (UMLS CUI [1])
C0193388 (UMLS CUI [2])
C3641250 (UMLS CUI [3])
Alanine aminotransferase measurement Quantity
Item
alt > 1.2 x uln on two occasions documented within 8 weeks before initiation of treatment.
boolean
C0201836 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Therapeutic procedure Willing | Clinical Study Follow-up Adherence
Item
able and likely to attend regularly for treatment and follow-up.
boolean
C0087111 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1510802 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods
Item
adequate contraception for males and females during treatment and follow-up (written confirmation).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Liver Cirrhosis Evidence of
Item
patients with evidence of cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Decompensated liver disease | Serum total bilirubin measurement | Serum albumin measurement | Prothrombin time increased | Quick Test for Liver Function | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy
Item
decompensated liver disease, as marked by: bilirubin greater than 20 micromol/l or serum albumin <35 g/l or prothrombin time greater than 3 seconds prolonged or quick test below 70% or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
boolean
C4075847 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
C0151872 (UMLS CUI [4])
C0086890 (UMLS CUI [5])
C0155789 (UMLS CUI [6])
C0003962 (UMLS CUI [7])
C0019151 (UMLS CUI [8])
Interferon therapy Systemic | Antiviral Agents Systemic | systemic steroids | Therapeutic immunosuppression | Investigational New Drugs
Item
systemic ifn treatment, systemic antiviral agents, systemic corticosteroids, immune suppressive treatment or any investigational drug within 3 months of entry to this protocol.
boolean
C0279030 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003451 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
Alanine aminotransferase measurement Quantity
Item
patients with alt levels greater than 10 times uln will not be enrolled but may be followed until three consecutive determinations within 2 months are below this level.
boolean
C0201836 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential Contraceptive methods Inadequate | spouse Contraceptive methods Inadequate
Item
pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0162409 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Systemic disease Significant | Illness Major | Liver diseases | Congestive heart failure | Myocardial Ischemia | Angina Pectoris | Cerebrovascular Disorders | Kidney Failure | Creatinine clearance measurement | Organ Transplantation | Mental disorders Serious | Depressive disorder | anaphylaxis
Item
significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, anaphylactic disorder.
boolean
C0442893 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0151744 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0007820 (UMLS CUI [7])
C0035078 (UMLS CUI [8])
C0373595 (UMLS CUI [9])
C0029216 (UMLS CUI [10])
C0004936 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0011581 (UMLS CUI [12])
C0002792 (UMLS CUI [13])
Severe cytopenia Pre-existing | Hemoglobin | White Blood Cell Count procedure | Platelet Count measurement | Lymphocyte
Item
pre-existing severe cytopenia; hb<7 mmol/l, wbc <3x10e9/l, plt <100x10e9/l, lymphocyte <0.5x10e9/l.
boolean
C1263979 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0019046 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0024264 (UMLS CUI [5])
Autoimmune Diseases
Item
any history or presence of autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Liver carcinoma Evidence of | Alpha fetoprotein measurement | Ultrasonography | imaging study | Mass Suggestive of Malignant neoplasm of liver
Item
evidence of hepatocellular carcinoma; alpha-fetoprotein (afp) levels greater than 50 ng/ml and ultrasound (or other imaging study) within 6 months prior to the entry demonstrating a mass suggestive of liver cancer.
boolean
C2239176 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0201539 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
C1881134 (UMLS CUI [4])
C0577559 (UMLS CUI [5,1])
C0332299 (UMLS CUI [5,2])
C0345904 (UMLS CUI [5,3])
HIV Infections | HIV Antibody Measurement
Item
human immunodeficiency virus infection, as shown by presence of anti-hiv antibody.
boolean
C0019693 (UMLS CUI [1])
C3714540 (UMLS CUI [2])
Gaucher Disease
Item
patients with cerebroside metabolite abnormalities (e.g. gaucher's disease).
boolean
C0017205 (UMLS CUI [1])
Liver disease Causations | Hepatitis C | Hepatitis D Infection | Alcoholic Liver Diseases | Liver diseases Obesity Induced | Drug-Induced Liver Injury | Autoimmune liver disease | Hepatolenticular Degeneration | Hemochromatosis | alpha 1-Antitrypsin Deficiency
Item
other acquired or inherited causes of liver disease: hepatitis c, hepatitis d, alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune liver disease, wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency.
boolean
C0023895 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0023896 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0028754 (UMLS CUI [5,2])
C0205263 (UMLS CUI [5,3])
C0860207 (UMLS CUI [6])
C0400936 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0018995 (UMLS CUI [9])
C0221757 (UMLS CUI [10])
Condition Patient Inappropriate | Condition Interferes with Study Subject Participation Status | Condition Interferes with Clinical Trial Completion
Item
any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
boolean
C0348080 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])