chronic hepatitis B virus infection
Conditions
Interventions
Addition of peginterferon alfa-2a for 48 weeks in chronich hepatitis B patients
treated with nucleos(t)ide analogues.
Sponsors
Stichting Leveronderzoek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Chronic hepatitis B (HBsAg positive > six months) • HBeAg negative within six months prior to initiation of peginterferon alfa-2a • (Peg)interferon naïve or experienced patients may both participate • Treatment with nucleos(t)ide analogues for at least 1 year at screening • HBV DNA < 200 IU/ml during nucleos(t)ide analogue treatment (except Telbivudine) within one month prior to initiation of peginterferon alfa-2a • Compensated liver disease • Age > 18 years • Adequate contraception • Written informed consent
Exclusion criteria
Exclusion criteria: • Treatment with any investigational drug within 30 days of entry to this protocol • Current treatment with Telbivudine • Severe hepatitis activity as documented by ALT>10 x ULN • History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy) • Pre-existent neutropenia (neutrophils *1,500/mm3) or thrombocytopenia (platelets *90,000/mm3) • Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV) • Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson*s disease or alpha-1 antitrypsin deficiency • Alpha fetoprotein > 50 ng/ml • Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met) • Immune suppressive treatment within the previous 6 months • Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study. • Pregnancy, breast-feeding • Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant) • Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study • Substance abuse, such as alcohol (*80 g/day), I.V. drugs and inhaled drugs in the past 2 years. Current methadone usage is allowed. • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome • HBsAg decline > 1 log from baseline at week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes • HBsAg decline > 1 log at weeks 24 and 72 • HBsAg decline > 0.5 log at weeks 24 and 48 • HBsAg loss at weeks 48 and 72 | — |
Countries
Netherlands
Outcome results
None listed