a study on Hepatitis B
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.
A Phase IIIb, Randomized, Open-Label Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Patients in Children With HBeAg Positive Chronic Hepatitis B in the Immune-Tolerant Phase
Hepatitis B, Chronic Interferons Lamivudine Interferon-alpha Peginterferon alfa-2a Entecavir
Open to people ages 3–17
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
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)
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)
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