Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

Completed

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

In brief

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.

Key facts

Study ID

NCT01163240

Run by

Novartis Pharmaceuticals

People needed

1640

Starts

2009-06-01

Last updated by the study team

2011-09-27

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients ≥ 18 years of age
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Universidade de Campinas, Campinas — São Paulo, Brazil
• Beijing You'an Hosptial — Beijing, China
• The First Affiliated Hospital of Chongqing Med. University — Chongqing, China
• 1st Affliated Hospital of 3rd Military Med. Univ. of PLA — Chongqing, China
• Hebei Medical University The Third Hospital, Shijiazhuang — Hebei, China
• Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou — Henan, China
• Prince of Wales Hospital — Hong Kong, China
• Queen Mary Hospital — Hong Kong, China
• The Second Xiangya Hospital, Changsha — Hunan, China
• The Third Xiangya Hospital of Central South University, Changsha — Hunan, China
• Jiangsu Province Hospital, Nanjing — Jiangsu, China
• First Hospital University of Jilin, Changchun — Jilin City, China
• The First Affiliated Hospital of Medical College, Kunming — Kunming, China
• The First Affiliated Hospital of Lanzhou University — Lanzhou, China
• The First Affiliated Hospital of Soochow University — Suzhou, China
• The Children's Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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