HBeAg positive chronic Hepatitis B virus (ICD classification code: B18) MedDRA version: 8.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Trade Name: Pegasys
Pharmaceutical Form: Solution for injection
Sponsors
Roche Latvia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 18 and = 70 years • HBeAg positive patients: HBV DNA >500,000 copies/ml • HBsAg positive for at least 6 months, anti-HBs negative • Elevated serum ALT > 2x ULN but = 10x ULN as determined by two abnormal values taken >14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who have received any antiviral or IFN based therapy for their chronic hepatitis B before enrolment. • Women with ongoing pregnancy or who are breast feeding. • Evidence of decompensated liver disease including any one of the following: o Serum albumin 34 µmol/L o History of encephalopathy o History of variceal bleeding o Ascites • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV) • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia) • Previous or current hepatocellular carcinoma • History of or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensate liver disease • Alpha-fetoprotein levels of > 100 ng/ml. Patients with values of >20 ng/ml and =100 ng/ml may be enrolled, if hepatic neoplasia has been excluded by liver imaging • Neutrophil count 2 times the upper limit of normal at screening • Serum creatinine level > 1.5 times the upper limit of normal at screening • Severe psychiatric disease including 1. Current uncontrolled psychiatric disease, especially depression 2. Previous documented suicide attempts 3. Any patient with history of hospitalization for psychiatric disease, or current antidepressant medication or major tranquilizer should be reviewed by consultant psychiatrist regarding suitability for interferon therapy. • History of a severe seizure disorder or current anticonvulsant use • History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study • Thyroid disease uncontrolled by prescribed medications • Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration) • Evidence of drug abuse within one year of study entry • Alcohol intake of more than 3 standard drinks per day for men and 2 standard drinks for women (1 standard drink contains 10 g alcohol) • Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening • Inability or unwillingness to provide informed consent or abide by the requirements of the study, including scheduled blood tests and clinic appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to make PEGASYS® available for the treatment of patients with HBeAg-positive chronic hepatitis B.;Secondary Objective: To explore the safety of peginterferon alfa-2a given for 48 weeks in Lithuania, Latvia and Estonia for specific patient population with chronic hepatitis B.;Primary end point(s): • HBV DNA <100,000 cpm | — |
Countries
Estonia, Latvia, Lithuania
Outcome results
None listed