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Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Diseases; Hepatitis, Chronic; Hepatitis, Viral, Human; Hepatitis; Virus Diseases; Digestive System Diseases; Hepatitis B, Chronic; Hepatitis B; DNA Virus Infections

Phase: N/A

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: 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


Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.


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

- Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal, Buenos Aires C1425EFD, Argentina

Hospital de Clínicas de Porto Alegre, Porto, Alegre 90035-903, Brazil

Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia, Belém 66035-080, Brazil

Hospital Oswaldo Cruz - Universidade de Pernambuco, Recife 50100-130, Brazil

Instituto da Criança - HC FMUSP, São Paulo 05403-900, Brazil

Universidade de Campinas, Campinas, São Paulo 13083-887, Brazil

Beijing You'an Hosptial, Beijing 100069, China

1st Affliated Hospital of 3rd Military Med. Univ. of PLA, Chongqing 400038, China

The First Affiliated Hospital of Chongqing Med. University, Chongqing 400016, China

Hebei Medical University The Third Hospital, Shijiazhuang, Hebei 050051, China

Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou, Henan 450052, China

Prince of Wales Hospital, Hong Kong, China

Queen Mary Hospital, Hong Kong, China

The Second Xiangya Hospital, Changsha, Hunan 410011, China

The Third Xiangya Hospital of Central South University, Changsha, Hunan 410013, China

Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China

First Hospital University of Jilin, Changchun, Jilin 130021, China

The First Affiliated Hospital of Medical College, Kunming, Kunming 650032, China

The First Affiliated Hospital of Lanzhou University, Lanzhou 730000, China

The First Affiliated Hospital of Soochow University, Suzhou 215006, China

Institute of Hematol., Union Hospital, Tongji Med. College, Wuhan 430022, China

Second Hospital of Xian Jiaotong University, Xi'an 710004, China

Hospital of Chengdu Military Area Command, Kunming, Yunnan 650032, China

Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux, Aquitaine 33076, France

Hôpital Jeanne de Flandre, Lille 59037, France

Groupe Hospitalier Necker - Enfants Malades, Paris 75015, France

Hôpital de Haute Pierre, Strasbourg 67098, France

Peripheral University General Hospital of Alexandroupoli, Alexandroupolis 68100, Greece

"Agia Sofia" Childrens Hospital of Athens, Athens 11527, Greece

IASO Children's Hospital, Athens 15123, Greece

University General Hospital of Heraklion, Heraklion, Crete 71110, Greece

Childrens' General Hospital of Athens 'P&A Kyriakou', Goudi 11527, Greece

Dr. R. K. Jain Clinic, Bhopal 462016, India

Choithram Hospital and Research Centre, Indore 452014, India

St. John's Medical College Hospital, Banglaore, Karna 560034, India

Apollo Gleneagles Hospital, Kolkata 700054, India

TNMC and BYL Nair Charitable Hospital, Mumbai 400008, India

Maulana Azad Medical College & LNJP Hospital, New Delhi 110002, India

Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi, Bologna 40138, Italy

Istituto G. Gaslini Ospedale Pediatrico IRCCS, Genova 16147, Italy

Universita degli Studi "Federico II", Napoli 80131, Italy

Azienda Ospedaliero Universitaria Pisana, Pisa 56123, Italy

Ospedale Pediatrico Bambino Gesu, Roma 00165, Italy

Hospital Nacional Edgardo Rebagliati Martins, Lima 11, Peru

Hospital Nacional G A Yrigoyen, Lima 13, Peru

Instituto Nacional de Salud del Niño, Lima LI33, Peru

Philippine General Hospital, Ermita 1000, Philippines

Research Institute for Tropical Medicine, Muntinlupa City 1781, Philippines

National Kidney and Transplant Institute, Quezon City 1104, Philippines

Philippine Children's Medical Center, Quezon City 1100, Philippines

Wojewodzki Spital Bydgoszcz, Bydgoszcz 85-030, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow 31-202, Poland

Instytut Centrum Zdrowia Matki Polki, Lodz 93-338, Poland

"Matei Bals" Institute of Infectious Diseases, Bucharest 021105, Romania

Fundeni Clinical Institute, Bucharest 022328, Romania

V. Babes Pneumology and Infectious Diseases Clin. Hosp, Craiova 200515, Romania

Central Research Institute for Epidemiology of Rospotrebnadz, Moscow 11123, Russian Federation

Research Center of Children's Health, Moscow 119991, Russian Federation

Russian State Medical University, Moscow 117049, Russian Federation

Saint- Petersburg State Mtchnikov's Medical Academy, Saint Petersburg 194100, Russian Federation

Smolensk State Medical Academy, Smolensk 214019, Russian Federation

Research Institute for Infectious Childhood Diseases, St. Petersburg 197022, Russian Federation

KK Women's and Children's Hospital, Singapore 229899, Singapore

National University of Singapore, Singapore 119074, Singapore

Hospital Universitario San Cecilio, Granada, Andalucía 18012, Spain

Hospital Sant Joan de Deu, Barcelona, Cataluña 08950, Spain

Hospital Carlos III, Madrid 28029, Spain

Hospital Universitario de Getafe, Madrid 28905, Spain

Hospital Universitario La Paz, Madrid 28046, Spain

Hospital Universitario La Fe, Valencia 46009, Spain

Chung Shan Medical University Hospital, Taichung 402, Taiwan

Taichung Veteran's General Hospital, Taichung 40705, Taiwan

Cathay General Hospital, Taipei 10650, Taiwan

National Taiwan University Hospital, Taipei 100, Taiwan

Ramathibodi Hospital, Bangkok 10400, Thailand

Maharaj Nakorn Chiangmai Hospital, Chiang Mai 50200, Thailand

Birmingham Childrens Hospital, Birmingham B46NH, United Kingdom

St James's University Hospital, Leeds LS97TF, United Kingdom

Kings College Hospital, London SE5 9RS, United Kingdom

The Royal London Hospital, London E12AT, United Kingdom

Queen's Medical Centre, Nottingham NG72UH, United Kingdom

The Children's Hospital, Aurora, Colorado 80045, United States

Shands Hospital at University of Florida, Gainesville, Florida 32610, United States

Children's Hospital Boston, Boston, Massachusetts 02115, United States

Saint Vincent Healthcare Pediatric Specialty Clinics, Billings, Montana 59101, United States

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Additional Information

Starting date: June 2009
Last updated: September 26, 2011

Page last updated: August 23, 2015

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