a study of pegylated interferon alfa-2a in combination with lamivudine or entecavir compared with untreated control group in children with hepatitis b envelope antigen (hbeag)-positive chronic hepatitis b (chb) in the immune-tolerant phase

Conditions: Pediatric Immuno-Tolerant Chronic Hepatitis B

Summary: this randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2a (pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with hbeag positive chb in the immune tolerant phase. note: study recruitment has been terminated


Eligibility criteria:
inclusion criteria: * positive for hbsag and hbeag for more than 6 months prior to baseline * detectable hbv-dna (\>20,000 iu/ml) as measured by polymerization chain reaction (pcr) or hybridization on at least 2 occasions at least one month apart with the latest determination obtained less than or equal to (\</=) 42 days prior to baseline * compensated liver disease (child-pugh class a clinical classification) * either liver biopsy performed within 2 years prior to baseline showing no or minimal fibrosis (liver biopsy scores and stable normal alt levels (less than or equal to upper limit of normal \[uln\]) during the 6 months leading up to baseline (including two separate occasions at least 1 month apart over the 6 months prior to baseline). screening alt levels must be normal (\</= uln) or stable normal alt levels (\</= uln), during the 1 year leading up to baseline (including three separate occasions at least 1 month apart over the 1 year prior to baseline) and no signs of hepatocellular carcinoma (hcc), advanced fibrosis/cirrhosis, or splenomegaly on liver abdominal ultrasound at screening. screening alt levels must be normal (\</= uln) exclusion criteria: * participants who have received investigational drugs or licensed treatments with anti hbv activity (exception: participants who have had a limited \[\</= 7-day\] course of acyclovir for herpetic lesions more than 1 month before the study baseline visit are not excluded) * participants who have participated in any other clinical trial or who have received any investigational drug within 6 months prior to baseline * known hypersensitivity to interferon (ifn), pegylated interferon-alfa-2a or lamivudine or entecavir * positive test results at screening for hepatitis a virus immunoglobulin m (igm) antibody (ab), anti-hepatitis c virus (hcv) ab, anti- hepatitis d (hdv) ab or anti-human immunodeficiency virus (hiv) ab * decompensated liver disease (e.g., child-pugh class b or c clinical classification or clinical evidence such as ascites or varices) * advanced fibrosis or cirrhosis * suspicion of hcc on liver abdominal ultrasound (all patients to have liver abdominal ultrasound within 6 months prior to baseline) * history or other evidence of a medical condition associated with chronic liver disease other than chb including metabolic liver diseases such as hemochromatosis, wilson's disease or alpha-1 anti-trypsin deficiency * active substance abuse within 6 months prior to screening * sexually active females of childbearing potential and sexually active males who are not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment * females who are pregnant or who are breastfeeding (females of childbearing potential who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded)