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PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
CompletedPhase 4
Sponsor: Foundation for Liver Research
Conditions: Chronic Hepatitis B
Interventions: Peginterferon alfa-2a, Nucleos(t)ide analogue
Countries: Canada, Netherlands
This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Chronic hepatitis B (HBsAg positive \> 6 months) * HBeAg negative within six months prior to initiation of peginterferon alfa-2a * HBV DNA \< 200 IU/ml during nucleos(t)ide analogue (except Telbivudine) treatment within one month prior to initiation of peginterferon alfa-2a * Compensated liver disease * Age \> 18 years * Written informed consent 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. * 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
Locations (8)
- Toronto, Ontario, Canada
- Rotterdam, South Holland, Netherlands
- Amsterdam, Netherlands
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Delft, Netherlands
- Haarlem, Netherlands
- Utrecht, Netherlands