Epidemiological Study in Children and Adolescents With Chronic Hepatitis B (EPIC B)
Status
Conditions
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Male or female, 2 to less than 18 years of age.
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Documented chronic hepatitis B defined by all of the following:
- Clinical history compatible with chronic hepatitis B,Detectable serum HBsAg at the time of the study and at least one other documentation of HBsAg positive at least 6 months prior to inclusion HBeAg-positive or HBeAg-negative Serum ALT of all levels subject or subject's parent or legal guardian must be willing and able to provide written informed consent for participation in the study.
Exclusion criteria
- Patients ≥ 18 years of age
- Other protocol-defined inclusion/exclusion criteria may apply
Trial design
1,640 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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