Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

NCT ID: NCT01163240

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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pediatric

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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The Children's Hospital

Aurora, Colorado, United States

Site Status

Shands Hospital at University of Florida

Gainesville, Florida, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Saint Vincent Healthcare Pediatric Specialty Clinics

Billings, Montana, United States

Site Status

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal

Buenos Aires, , Argentina

Site Status

Hospital de Clínicas de Porto Alegre, Porto

Alegre, , Brazil

Site Status

Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia

Belém, , Brazil

Site Status

Hospital Oswaldo Cruz - Universidade de Pernambuco

Recife, , Brazil

Site Status

Instituto da Criança - HC FMUSP

São Paulo, , Brazil

Site Status

Universidade de Campinas, Campinas

São Paulo, , Brazil

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Beijing You'an Hosptial

Beijing, , China

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The First Affiliated Hospital of Chongqing Med. University

Chongqing, , China

Site Status

1st Affliated Hospital of 3rd Military Med. Univ. of PLA

Chongqing, , China

Site Status

Hebei Medical University The Third Hospital, Shijiazhuang

Hebei, , China

Site Status

Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou

Henan, , China

Site Status

Prince of Wales Hospital

Hong Kong, , China

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Queen Mary Hospital

Hong Kong, , China

Site Status

The Second Xiangya Hospital, Changsha

Hunan, , China

Site Status

The Third Xiangya Hospital of Central South University, Changsha

Hunan, , China

Site Status

Jiangsu Province Hospital, Nanjing

Jiangsu, , China

Site Status

First Hospital University of Jilin, Changchun

Jilin, , China

Site Status

The First Affiliated Hospital of Medical College, Kunming

Kunming, , China

Site Status

The First Affiliated Hospital of Lanzhou University

Lanzhou, , China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status

Institute of Hematol., Union Hospital, Tongji Med. College

Wuhan, , China

Site Status

Second Hospital of Xian Jiaotong University

Xi'an, , China

Site Status

Hospital of Chengdu Military Area Command, Kunming

Yunnan, , China

Site Status

Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux

Aquitaine, , France

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Hôpital Jeanne de Flandre

Lille, , France

Site Status

Groupe Hospitalier Necker - Enfants Malades

Paris, , France

Site Status

Hôpital de Haute Pierre

Strasbourg, , France

Site Status

Peripheral University General Hospital of Alexandroupoli

Alexandroupoli, , Greece

Site Status

"Agia Sofia" Childrens Hospital of Athens

Athens, , Greece

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IASO Children's Hospital

Athens, , Greece

Site Status

University General Hospital of Heraklion, Heraklion

Crete, , Greece

Site Status

Childrens' General Hospital of Athens 'P&A Kyriakou'

Goudi, , Greece

Site Status

Dr. R. K. Jain Clinic

Bhopal, , India

Site Status

Choithram Hospital and Research Centre

Indore, , India

Site Status

St. John's Medical College Hospital, Banglaore

Karna, , India

Site Status

Apollo Gleneagles Hospital

Kolkata, , India

Site Status

TNMC and BYL Nair Charitable Hospital

Mumbai, , India

Site Status

Maulana Azad Medical College & LNJP Hospital

New Delhi, , India

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Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

Istituto G. Gaslini Ospedale Pediatrico IRCCS

Genova, , Italy

Site Status

Universita degli Studi "Federico II"

Napoli, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status

Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Site Status

Hospital Nacional Edgardo Rebagliati Martins

Lima, , Peru

Site Status

Hospital Nacional G A Yrigoyen

Lima, , Peru

Site Status

Instituto Nacional de Salud del Niño

Lima, , Peru

Site Status

Research Institute for Tropical Medicine

City of Muntinlupa, , Philippines

Site Status

Philippine General Hospital

Ermita, , Philippines

Site Status

Philippine Children's Medical Center

Quezon City, , Philippines

Site Status

National Kidney and Transplant Institute

Quezon City, , Philippines

Site Status

Wojewodzki Spital Bydgoszcz

Bydgoszcz, , Poland

Site Status

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, , Poland

Site Status

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Site Status

"Matei Bals" Institute of Infectious Diseases

Bucharest, , Romania

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Fundeni Clinical Institute

Bucharest, , Romania

Site Status

V. Babes Pneumology and Infectious Diseases Clin. Hosp

Craiova, , Romania

Site Status

Central Research Institute for Epidemiology of Rospotrebnadz

Moscow, , Russia

Site Status

Russian State Medical University

Moscow, , Russia

Site Status

Research Center of Children's Health

Moscow, , Russia

Site Status

Saint- Petersburg State Mtchnikov's Medical Academy

Saint Petersburg, , Russia

Site Status

Research Institute for Infectious Childhood Diseases

Saint Petersburg, , Russia

Site Status

Smolensk State Medical Academy

Smolensk, , Russia

Site Status

National University of Singapore

Singapore, , Singapore

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Hospital Universitario San Cecilio, Granada

Andalucía, , Spain

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Hospital Sant Joan de Deu, Barcelona

Cataluña, , Spain

Site Status

Hospital Carlos III

Madrid, , Spain

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Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario de Getafe

Madrid, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

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Taichung Veteran's General Hospital

Taichung, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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Cathay General Hospital

Taipei, , Taiwan

Site Status

Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, , Thailand

Site Status

Birmingham Childrens Hospital

Birmingham, , United Kingdom

Site Status

St James's University Hospital

Leeds, , United Kingdom

Site Status

The Royal London Hospital

London, , United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Queen's Medical Centre

Nottingham, , United Kingdom

Site Status

Countries

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

Other Identifiers

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CLDT600A2414

Identifier Type: -

Identifier Source: org_study_id