Clinical trial NCT01163240: Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
Official title: A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Keywords: hepatitis B
HBV
chronic hepatitis B
pediatric
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 1640
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Children's Hospital
state: Colorado
city: Gainesville
country: United States
facility: Shands Hospital at University of Florida
state: Florida
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Billings
country: United States
facility: Saint Vincent Healthcare Pediatric Specialty Clinics
state: Montana
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal
city: Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre, Porto
city: Belém
country: Brazil
facility: Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia
city: Recife
country: Brazil
facility: Hospital Oswaldo Cruz - Universidade de Pernambuco
city: São Paulo
country: Brazil
facility: Instituto da Criança - HC FMUSP
city: São Paulo
country: Brazil
facility: Universidade de Campinas, Campinas
city: Beijing
country: China
facility: Beijing You'an Hosptial
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Med. University
city: Chongqing
country: China
facility: 1st Affliated Hospital of 3rd Military Med. Univ. of PLA
city: Hebei
country: China
facility: Hebei Medical University The Third Hospital, Shijiazhuang
city: Henan
country: China
facility: Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hunan
country: China
facility: The Second Xiangya Hospital, Changsha
city: Hunan
country: China
facility: The Third Xiangya Hospital of Central South University, Changsha
city: Jiangsu
country: China
facility: Jiangsu Province Hospital, Nanjing
city: Jilin
country: China
facility: First Hospital University of Jilin, Changchun
city: Kunming
country: China
facility: The First Affiliated Hospital of Medical College, Kunming
city: Lanzhou
country: China
facility: The First Affiliated Hospital of Lanzhou University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Wuhan
country: China
facility: Institute of Hematol., Union Hospital, Tongji Med. College
city: Xi'an
country: China
facility: Second Hospital of Xian Jiaotong University
city: Yunnan
country: China
facility: Hospital of Chengdu Military Area Command, Kunming
city: Aquitaine
country: France
facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
city: Paris
country: France
facility: Groupe Hospitalier Necker - Enfants Malades
city: Strasbourg
country: France
facility: Hôpital de Haute Pierre
city: Alexandroupolis
country: Greece
facility: Peripheral University General Hospital of Alexandroupoli
city: Athens
country: Greece
facility: "Agia Sofia" Childrens Hospital of Athens
city: Athens
country: Greece
facility: IASO Children's Hospital
city: Crete
country: Greece
facility: University General Hospital of Heraklion, Heraklion
city: Goudi
country: Greece
facility: Childrens' General Hospital of Athens 'P&A Kyriakou'
city: Bhopal
country: India
facility: Dr. R. K. Jain Clinic
city: Indore
country: India
facility: Choithram Hospital and Research Centre
city: Karna
country: India
facility: St. John's Medical College Hospital, Banglaore
city: Kolkata
country: India
facility: Apollo Gleneagles Hospital
city: Mumbai
country: India
facility: TNMC and BYL Nair Charitable Hospital
city: New Delhi
country: India
facility: Maulana Azad Medical College & LNJP Hospital
city: Bologna
country: Italy
facility: Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi
city: Genova
country: Italy
facility: Istituto G. Gaslini Ospedale Pediatrico IRCCS
city: Napoli
country: Italy
facility: Universita degli Studi "Federico II"
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesu
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Hospital Nacional G A Yrigoyen
city: Lima
country: Peru
facility: Instituto Nacional de Salud del Niño
city: Ermita
country: Philippines
facility: Philippine General Hospital
city: Muntinlupa City
country: Philippines
facility: Research Institute for Tropical Medicine
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center
city: Quezon City
country: Philippines
facility: National Kidney and Transplant Institute
city: Bydgoszcz
country: Poland
facility: Wojewodzki Spital Bydgoszcz
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Bucharest
country: Romania
facility: "Matei Bals" Institute of Infectious Diseases
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Craiova
country: Romania
facility: V. Babes Pneumology and Infectious Diseases Clin. Hosp
city: Moscow
country: Russian Federation
facility: Central Research Institute for Epidemiology of Rospotrebnadz
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: Research Center of Children's Health
city: Saint Petersburg
country: Russian Federation
facility: Saint- Petersburg State Mtchnikov's Medical Academy
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: St. Petersburg
country: Russian Federation
facility: Research Institute for Infectious Childhood Diseases
city: Singapore
country: Singapore
facility: National University of Singapore
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Andalucía
country: Spain
facility: Hospital Universitario San Cecilio, Granada
city: Cataluña
country: Spain
facility: Hospital Sant Joan de Deu, Barcelona
city: Madrid
country: Spain
facility: Hospital Carlos III
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veteran's General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Childrens Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmceuticals
role: STUDY_DIRECTOR
References: