Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01163240

Acronym

EPIC B

Enrollment

1640

Registered

2010-07-15

Start date

2009-06-30

Completion date

Unknown

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Diseases, DNA Virus Infections, Hepatitis, Hepatitis B, Hepatitis B, Chronic, Hepatitis, Chronic, Hepatitis, Viral, Human, Liver Diseases, Virus Diseases

Keywords

hepatitis B, HBV, chronic hepatitis B, pediatric

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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	2 yrs

Countries

Argentina, Brazil, China, France, Greece, India, Italy, Peru, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Thailand, United Kingdom, United States

Outcome results