PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients

• Status: Completed
• Trial end date: 2019-10-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Liver Research
• Collaborator: Hoffmann-La Roche
• Treatments: Adefovir; Entecavir; Interferon-alpha; Peginterferon alfa-2a; Tenofovir

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