Division of Gastroenterology, Hepatology and Nutrition
A comparative study of the antiviral efficacy and safety of entecavir (ETV) versus placebo in pediatric subjects with chronic hepatitis B virus (HBV) infection who are HBeAg-positive
Principal Investigator: Maureen Jonas, MD
Department: Gastroenterology, Center for Childhood Liver Disease
Protocol Status: Open for Recruitment
Trial Description: This is a study of the use of entecavir, an oral medication, in children with chronic hepatitis B who have abnormal liver enzymes. This medication is already approved for adults with chronic hepatitis B. This research will determine if the drug is safe and effective for children and adolescents. This is a randomized trial, which means that some subjects will receive active drug and some will receive placebo. After 48 weeks, if the hepatitis B has not responded, all subjects will be able to get study drug (entecavir).
Recruitment Info: The patient must be less than 18 years of age, have chronic hepatitis B and have abnormal liver enzymes. Further details are available on request.
PI contact: Maureen Jonas, MD
PI phone: Center for Childhood Liver Disease, 617-355-5837