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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pediatric |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Male or female, 2 to less than 18 years of age.
Documented chronic hepatitis B defined by all of the following:
Exclusion criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital | Aurora | Colorado | 80045 | United States | ||
| Shands Hospital at University of Florida |
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| 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 City | 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" | Naples | 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 |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D006521 | Hepatitis, Chronic |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D014777 | Virus Diseases |
| D004066 | Digestive System Diseases |
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D004266 | DNA Virus Infections |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
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