Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
- Conditions
- Liver DiseasesHepatitis, ChronicHepatitis, Viral, HumanHepatitisVirus DiseasesDigestive System DiseasesHepatitis B, ChronicHepatitis BDNA 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1640
Not provided
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (86)
Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux
🇫🇷Aquitaine, France
Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou
🇨🇳Henan, China
The Second Xiangya Hospital, Changsha
🇨🇳Hunan, China
Hôpital Jeanne de Flandre
🇫🇷Lille, France
Ospedale Pediatrico Bambino Gesu
🇮🇹Roma, Italy
Hospital Oswaldo Cruz - Universidade de Pernambuco
🇧🇷Recife, Brazil
1st Affliated Hospital of 3rd Military Med. Univ. of PLA
🇨🇳Chongqing, China
The First Affiliated Hospital of Medical College, Kunming
🇨🇳Kunming, China
The First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, China
Institute of Hematol., Union Hospital, Tongji Med. College
🇨🇳Wuhan, China
Second Hospital of Xian Jiaotong University
🇨🇳Xi'an, China
Hospital of Chengdu Military Area Command, Kunming
🇨🇳Yunnan, China
Instituto da Criança - HC FMUSP
🇧🇷São Paulo, Brazil
The First Affiliated Hospital of Chongqing Med. University
🇨🇳Chongqing, China
Hebei Medical University The Third Hospital, Shijiazhuang
🇨🇳Hebei, China
Prince of Wales Hospital
🇨🇳Hong Kong, China
Queen Mary Hospital
🇨🇳Hong Kong, 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, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Beijing You'an Hosptial
🇨🇳Beijing, China
Universidade de Campinas, Campinas
🇧🇷São Paulo, Brazil
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Childrens' General Hospital of Athens 'P&A Kyriakou'
🇬🇷Goudi, Greece
Hôpital de Haute Pierre
🇫🇷Strasbourg, France
Hospital Carlos III
🇪🇸Madrid, Spain
Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Hospital Sant Joan de Deu, Barcelona
🇪🇸Cataluña, Spain
Kings College Hospital
🇬🇧London, United Kingdom
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario San Cecilio, Granada
🇪🇸AndalucÃa, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Universitario de Getafe
🇪🇸Madrid, Spain
Research Institute for Infectious Childhood Diseases
🇷🇺St. Petersburg, Russian Federation
The Royal London Hospital
🇬🇧London, United Kingdom
Groupe Hospitalier Necker - Enfants Malades
🇫🇷Paris, France
Istituto G. Gaslini Ospedale Pediatrico IRCCS
🇮🇹Genova, Italy
Universita degli Studi "Federico II"
🇮🇹Napoli, Italy
TNMC and BYL Nair Charitable Hospital
🇮🇳Mumbai, India
Taichung Veteran's General Hospital
🇨🇳Taichung, Taiwan
Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal
🇦🇷Buenos Aires, Argentina
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
The Children's Hospital
🇺🇸Aurora, Colorado, United States
Shands Hospital at University of Florida
🇺🇸Gainesville, Florida, United States
Hospital de ClÃnicas de Porto Alegre, Porto
🇧🇷Alegre, Brazil
Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia
🇧🇷Belém, Brazil
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Peripheral University General Hospital of Alexandroupoli
🇬🇷Alexandroupolis, Greece
Maharaj Nakorn Chiangmai Hospital
🇹ðŸ‡Chiang Mai, Thailand
"Agia Sofia" Childrens Hospital of Athens
🇬🇷Athens, Greece
Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
National University of Singapore
🇸🇬Singapore, Singapore
Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand
St James's University Hospital
🇬🇧Leeds, United Kingdom
Birmingham Childrens Hospital
🇬🇧Birmingham, United Kingdom
Dr. R. K. Jain Clinic
🇮🇳Bhopal, India
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
University General Hospital of Heraklion, Heraklion
🇬🇷Crete, Greece
Choithram Hospital and Research Centre
🇮🇳Indore, India
St. John's Medical College Hospital, Banglaore
🇮🇳Karna, India
Maulana Azad Medical College & LNJP Hospital
🇮🇳New Delhi, India
Apollo Gleneagles Hospital
🇮🇳Kolkata, India
Instituto Nacional de Salud del Niño
🇵🇪Lima, Peru
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore
Central Research Institute for Epidemiology of Rospotrebnadz
🇷🇺Moscow, Russian Federation
Russian State Medical University
🇷🇺Moscow, Russian Federation
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
IASO Children's Hospital
🇬🇷Athens, Greece
Philippine General Hospital
🇵ðŸ‡Ermita, Philippines
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Saint- Petersburg State Mtchnikov's Medical Academy
🇷🇺Saint Petersburg, Russian Federation
Hospital Nacional Edgardo Rebagliati Martins
🇵🇪Lima, Peru
Research Institute for Tropical Medicine
🇵ðŸ‡Muntinlupa City, Philippines
V. Babes Pneumology and Infectious Diseases Clin. Hosp
🇷🇴Craiova, Romania
Hospital Nacional G A Yrigoyen
🇵🇪Lima, Peru
Philippine Children's Medical Center
🇵ðŸ‡Quezon City, Philippines
National Kidney and Transplant Institute
🇵ðŸ‡Quezon City, Philippines
Wojewodzki Spital Bydgoszcz
🇵🇱Bydgoszcz, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Krakow, Poland
"Matei Bals" Institute of Infectious Diseases
🇷🇴Bucharest, Romania
Smolensk State Medical Academy
🇷🇺Smolensk, Russian Federation
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Research Center of Children's Health
🇷🇺Moscow, Russian Federation
Cathay General Hospital
🇨🇳Taipei, Taiwan
Saint Vincent Healthcare Pediatric Specialty Clinics
🇺🇸Billings, Montana, United States