The hypothesis of this study is that Lamivudine will be well-tolerated, safe and effective compared to placebo when used as treatment for chronic hepatitis B in children.
The first aim i s to compare the efficacy of lamivudine versus placebo in children with chronic hepatitis B with regard to complete virologic response (loss of detectable HbeAg and HBV DNA in serum) and sustained normalization of serum alanine aminotransferase (ALT).
The second aim i s to compare the safety and tolerability of lamivudine versus placebo in children with chronic HBV infection. This protocol was designed as a phase 3 trial to determine the efficacy and safety of 3 mg/kg Lamivudine in children aged 2 to 16 years with chronic e-antigen positive hepatitis B. This was a randomized, double blind, placebo-controlled study enrolling two patients in the treatment arm for every one control patient enrolled. Two patients enrolled in our center. One patient has finished uneventfully but remains positive for hepatitis e-antigen. This patient was eligible to be enrolled in a follow-on two year study of continued open label treatment with Lamivudine which the patient has already enrolled in. We do not yet know whether she was originally in the treatment or the control group. The other patient is still being treated in the 1681 protocol, and thus we do not know her current HBV antigen status. No serious adverse or unanticipated events or side effects have occurred thus far during treatment. There have been no changes to the protocol. It is anticipated that the last subject will finish the protocol and be enrolled into the follow-on two year study with open label treatment with Lamivudine if still HBV e-antigen positive or two year observational/monitoring study to assess the durability of response to Lamivudine and natural history of spontaneous e-antigen conversion if the patient is negative for e-antigen at the end of this treatment study. As the study is not completed around the world yet, no data are yet available on the preliminary end of treatment response to Lamivudine vs. placebo in the treatment of HBV in children.
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