48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA <10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison with pegylated interferon (PEG-IFN) monotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Chronic hepatitis B

• Biopsy performed within one year prior to screening or during screening

• ALT > 1.5 x ULN

• HBeAg negative, anti-HBeAg positive

• HBV DNA > 10E5 copies/ml

• Age 18-70 years

• Written informed consent

• Hepatic imaging without evidence of HCC

• All fertile males and females must be using two forms of effective contraception

Exclusion Criteria:

• Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol

• Severe hepatitis activity as documented by ALT > 10 x ULN

• Advanced liver disease

• Pre-existent leucopenia or thrombopenia

• Co-infection with HCV,HDV or HIV

• Other acquired or inherited causes of liver disease

• Alpha fetoprotein > 50 ng/ml.

• Evidence of severe renal disease

• Hyper- or hypothyroidism

• Significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes

• Immune suppressive treatment within the previous 6 months

• Contra-indications for alpha-interferon therapy

• Pregnancy, breast-feeding

• Any medical condition requiring chronic systemic administration of steroids

• Substance alcohol or drug abuse

• Subjects with clinically significant retinal abnormalities

• Subjects with clinically significant hearing abnormalities

• Hemoglobinopathies

• Subjects with known hypersensitivity to ribavirin