Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether it is possible to augment the response of patients with HBeAg-positive chronic hepatitis B to entecavir by using a temporary peginterferon alpha-2a add-on strategy

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

Details

• Lead Sponsor: Foundation for Liver Research
• Treatments: Entecavir; Interferon-alpha; Interferons; Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• Chronic hepatitis B (HBsAg positive > 6 months)

• HBeAg positive, anti-HBe negative at screening

• ALT > 1.3 x ULN within 60 days prior to screening and during screening

• Liver biopsy performed within 2 years prior to screening or during screening

• Age > 18 years

• Written informed consent

• Adequate contraception for males and females during treatment and follow up; negative pregnancy test (for women of childbearing potential)

Exclusion Criteria:

• Antiviral therapy against HBV within the previous 6 months

• Treatment with any investigational drug within 30 days of screening

• Previous treatment with lamivudine or telbivudine for more than six months

• 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 or human immunodeficiency virus (HIV)

• Other acquired or inherited causes of liver disease (i.e. 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 alpha-interferon therapy like suspected hypersensitivity to interferon or PEG-interferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.

• Pregnancy, lactation

• 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 principal investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study