Age
Item
male and female patients >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis B HBeAg positive Serology | Chronic Hepatitis B HBeAg Serology negative | Liver Cirrhosis | Liver Cirrhosis Absent
Item
hepatitis b virus e antigen (hbeag) positive or hbeag negative serologically proven chronic hepatitis b (chb) with or without cirrhosis (histologically verified at some point in the past)
boolean
C0524909 (UMLS CUI [1,1])
C0392390 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C0524909 (UMLS CUI [2,1])
C0019167 (UMLS CUI [2,2])
C0919674 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hepatitis B DNA Measurement
Item
baseline hepatitis b virus (hbv) dna >2,000 iu/ml
boolean
C3641250 (UMLS CUI [1])
Alanine aminotransferase increased
Item
elevated serum alanine aminotransferase (alt) > upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Nucleoside Analogs | Nucleotide analog
Item
patients treated with previous nucleos(t)ide analogs (nas) therapy are eligible for this study
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
Medical contraindication Peginterferon alfa-2a | Medical contraindication Pegasys | Mental Disorders, Severe | Immune System Disease | Liver Dysfunction Severe | Decompensated cirrhosis of liver | Retinal Disease Severe | Thyroid dysfunction Severe | Hepatitis, Autoimmune | Heart Disease Severe Pre-existing | Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon-alpha | Hypersensitivity Interferon-alpha Pharmaceutical Excipient
Item
patients who have contraindications for peginterferon alfa-2a (pegasys®) in accordance with the approved summary of product characteristics (e.g., severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
boolean
C1301624 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1176430 (UMLS CUI [2,2])
C4046029 (UMLS CUI [3])
C0021053 (UMLS CUI [4])
C0086565 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1619727 (UMLS CUI [6])
C0035309 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0348024 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0241910 (UMLS CUI [9])
C0018799 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C2347662 (UMLS CUI [10,3])
C0020517 (UMLS CUI [11,1])
C0013230 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0002199 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0002199 (UMLS CUI [13,2])
C0015237 (UMLS CUI [13,3])
Alanine aminotransferase increased | Liver carcinoma
Item
patients with alt > 10 x uln or evidence of hepatocellular carcinoma
boolean
C0151905 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Coinfection Hepatitis A Virus Serology | HCV coinfection Serology | HIV coinfection Serology | Coinfection Hepatitis Delta Virus Serology
Item
patients with serological evidence of co-infection with hepatitis a virus, hepatitis c, human immunodeficiency virus or hepatitis d virus
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C1698259 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
C0275524 (UMLS CUI [4,1])
C0011220 (UMLS CUI [4,2])
C0036743 (UMLS CUI [4,3])
Decompensated liver disease
Item
patients with decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Transplantation of liver | Transplantation of liver Planned
Item
a history of liver transplantation or planned for liver transplantation
boolean
C0023911 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
telbivudine | Peginterferon alfa-2a Contraindicated
Item
concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contraindicated according to telbivudine label)
boolean
C1453933 (UMLS CUI [1])
C0391001 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])