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Clinical Trials/NCT01163240
NCT01163240
Completed
N/A

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

Novartis Pharmaceuticals86 sites in 9 countries1,640 target enrollmentJune 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Liver Diseases
Sponsor
Novartis Pharmaceuticals
Enrollment
1640
Locations
86
Primary Endpoint
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
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
September 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

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

Study Sites (86)

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