chronic HBV infection
Conditions
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic hepatitis B (HBsAg positive > 6 months) - Biopsy performed within one year prior to screening or during screening - ALT > 1.5 x ULN on two occasions within 2 months prior to randomization (normal ALT values in between are allowed) - HBeAg negative, anti-HBeAg positive on two occasions within 2 months prior to randomization - HBV DNA > 105 copies/ml (centrally measured by Taqman PCR) within 2 months prior to randomization - Age 18-70 years - Written informed consent - Hepatic imaging (US, CT or MRI) without evidence of hepatocellular carcinoma within 3 months prior to randomization - Adequate contraception for males and females during treatment and follow up (written confirmation); 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 hepatitis C, hepatitis D or human immunodeficiency virus (HIV) - Other acquired or inherited causes of liver disease - Alpha fetoprotein > 50 ng/ml. - Serum creatinine level > 1.5 times the upper limit of normal at screening or evidence of severe renal disease - Hyper- or hypothyroidism (Subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.) - Other significant medical illness that might interfere with this study: significant cardiovascular or 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) - Immune suppressive treatment within the previous 6 months - Pregnancy, breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 <104 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison with PEG-IFN monotherapy.;Secondary Objective: - to study differences in outcome between one year PEG-IFN-Ribavirin combination therapy and PEG-IFN monotherapy on suppression of HBV DNA -to study differences in outcome between one year PEG-IFN-Ribavirin combination therapy and PEG-IFN monotherapy on loss of serum HBsAg, - to study differences in outcome between one year PEG-IFN-Ribavirin combination therapy and PEG-IFN monotherapy on histological improvement - to study differences in outcome between one year PEG-IFN-Ribavirin combination therapy and PEG-IFN monotherapy on combined virological, biochemical and histological response ;Primary end point(s): The combined presence of HBV DNA level < 104 copies/ml and ALT normalization at the end of follow-up. | — |
Countries
Austria, Germany
Outcome results
None listed