Epidemiological Study in Children and Adolescents With Chronic Hepatitis B



Status:Archived
Conditions:Infectious Disease, Gastrointestinal, Hepatitis, Digestive Disease
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2009

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A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B


The purpose of this study is to collect epidemiological data in children and adolescents
with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive
disease with associated ALT levels , active HBeAg negative disease and decompensated CHB in
the pediatric population. Family history and history of HBV transmission is essential to
assess the course of the disease and can be used to determine the best mode of treatment
This information will be used to assist with the feasibility and design of studies for the
Novartis clinical pediatric development program, as the current epidemiology of ediatric CHB
is not accurately known in Western countries or the rest of the world making pediatric
studies difficult to plan and conduct. This study forms part of the Novartis Pediatric
Investigational Plan, a post marketing approval commitment to the EMEA Pediatric Committee.



We found this trial at
5
sites
300 Longwood Avenue
Boston, Massachusetts 02115
617-355-6000
Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
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Boston, MA
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Gainesville, Florida 32611
(352) 392-3261
University of Florida Gainesville UF has a long history of established programs in international education,...
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Gainesville, FL
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Billings, MT
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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from
New Brunswick, NJ
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