Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

Hepatitis B Clinical Trial

— EPIC B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163240
• Other study ID #: CLDT600A2414
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: September 26, 2011
• Start date: June 2009

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaPhilippines: Bureau of Food and DrugsArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Committee of Ethics in ResearchFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéGreece: Ministry of Health and WelfareRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1640
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No