a study on Hepatitis B
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN)
This multicenter, randomized, controlled study will be conducted by the pediatric centers within the NIDDK-sponsored Hepatitis B Research Network (HBRN). Children age 3-<18 years with immunotolerant chronic hepatitis B (CHB) infection who fulfill the entry criteria will receive entecavir as monotherapy for 8 weeks and then combination therapy with entecavir and pegylated interferon by weekly subcutaneous injection until week 48. Children will be followed for 96 weeks which is 48 weeks after discontinuation of therapy.
Assessment will be undertaken at baseline, weeks 4, 8, 10, 12, 14, & 16, then every 4 weeks until week 48, and then at week 52, 56, 60, 72, 84 and 96. Data collected will describe baseline demographics, symptoms of liver disease, intercurrent illnesses, and findings on physical examination. Blood work will be drawn to measure markers of viral and liver disease status, assessment of drug adverse effects, and for research biospecimen banking.
Participants will continue on therapy until week 48 and complete the full study follow-up protocol thereafter, including those who undergo seroconversion to anti-HBe or anti-HBs before reaching week 48. Participants who experience a sustained elevation of ALT will be eligible to receive treatment as recommended by their hepatologist and will continue to complete the study follow-up protocol. Participants who exhibit adverse effects of therapy will undergo dose adjustment or discontinuation of therapy as detailed in the protocol, and will continue to complete the study follow-up protocol.
Hepatitis B Interferons Peginterferon alfa-2a Interferon-alpha Entecavir
Open to people ages 3 years to 18 years
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