Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

Completed

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

• Registration Number: NCT01163240
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1640

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (86)

The Children's Hospital; 🇺🇸 Aurora, Colorado, United States

Shands Hospital at University of Florida; 🇺🇸 Gainesville, Florida, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Saint Vincent Healthcare Pediatric Specialty Clinics; 🇺🇸 Billings, Montana, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

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

Hospital de Clínicas de Porto Alegre, Porto; 🇧🇷 Alegre, Brazil

Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia; 🇧🇷 Belém, Brazil

Hospital Oswaldo Cruz - Universidade de Pernambuco; 🇧🇷 Recife, Brazil

Instituto da Criança - HC FMUSP; 🇧🇷 São Paulo, Brazil

Scroll for more (76 remaining)