MedTrace Logo

Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

NCT01163240 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1640

Last updated 2011-09-27

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-09-30

Countries

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163240 on ClinicalTrials.gov