Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
EPIC B
A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B
1 other identifier
observational
1,640
18 countries
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2010
CompletedFirst Posted
Study publicly available on registry
July 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedSeptember 27, 2011
September 1, 2011
2.3 years
July 14, 2010
September 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
pediatric
Eligibility Criteria
Eligible patients will be identified in the treatment centers by the investigators. These patients can include those patients being referred to the practice or patients currently being seen by the investigator who are male or female, children or adolescents with chronic hepatitis B, aged 2 to \< 18 years . Patients visiting the center during the 2 year enrolment period may be eligible for the study. This visit will constitute the data captured for the "current disease state" in the questionnaire. Patients will be recruited from Asian and Western countries.
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:
You may not qualify if:
- Patients ≥ 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
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
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
The First Affiliated Hospital of Chongqing Med. University
Chongqing, 400016, China
1st Affliated Hospital of 3rd Military Med. Univ. of PLA
Chongqing, 400038, 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
Alexandroupoli, 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
Research Institute for Tropical Medicine
City of Muntinlupa, 1781, Philippines
Philippine General Hospital
Ermita, 1000, Philippines
Philippine Children's Medical Center
Quezon City, 1100, Philippines
National Kidney and Transplant Institute
Quezon City, 1104, 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, Russia
Russian State Medical University
Moscow, 117049, Russia
Research Center of Children's Health
Moscow, 119991, Russia
Saint- Petersburg State Mtchnikov's Medical Academy
Saint Petersburg, 194100, Russia
Research Institute for Infectious Childhood Diseases
Saint Petersburg, 197022, Russia
Smolensk State Medical Academy
Smolensk, 214019, Russia
National University of Singapore
Singapore, 119074, Singapore
KK Women's and Children's Hospital
Singapore, 229899, 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 La Paz
Madrid, 28046, Spain
Hospital Universitario de Getafe
Madrid, 28905, Spain
Hospital Universitario La Fe
Valencia, 46009, Spain
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Taichung Veteran's General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Cathay General Hospital
Taipei, 10650, 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
The Royal London Hospital
London, E12AT, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Queen's Medical Centre
Nottingham, NG72UH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2010
First Posted
July 15, 2010
Study Start
June 1, 2009
Primary Completion
September 1, 2011
Last Updated
September 27, 2011
Record last verified: 2011-09