Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study) - ARES

Active, not recruiting

• Conditions: Chronic hepatitis B virus infection; MedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B

• Registration Number: EUCTR2008-006239-11-NL
• Lead Sponsor: Stichting Lever Onderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified