Epidemiological Study 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.

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Key information

Conditions

Liver Diseases Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female, 2 to less than 18 years of age.
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

Treatment and study plan

Primary outcomes

Obtain epidemiological data in children and adolescents with chronic hepatitis B that will assist the feasibility and design of studies for the Novartis telbivudine clinical pediatric development program

Time frame: 2 yrs

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: EPIC B

Important dates

Study start: 2009
Primary completion: 2011
First posted: Jul 15, 2010
Registry last updated: Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed