Liver DiseasesEPIC BNCT01163240
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
An observational study of Liver Diseases and Hepatitis, Chronic, run by Novartis Pharmaceuticals at 86 sites in 18 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human
- How many people
- 1,640 participants
- Where
- 86 sitesin 18 countries
- Study dates
- Jun 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients ≥ 18 years of age
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
86 sites in 18 countries.
86 sites in 18 countries
China17 sites
Beijing You'an Hosptial
Beijing, 100069
The First Affiliated Hospital of Chongqing Med. University
Chongqing, 400016
1st Affliated Hospital of 3rd Military Med. Univ. of PLA
Chongqing, 400038
Hebei Medical University The Third Hospital, Shijiazhuang
Hebei, 050051
Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou
Henan, 450052
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
The Second Xiangya Hospital, Changsha
Hunan, 410011
The Third Xiangya Hospital of Central South University, Changsha
Hunan, 410013
Jiangsu Province Hospital, Nanjing
Jiangsu, 210029
First Hospital University of Jilin, Changchun
Jilin City, 130021
The First Affiliated Hospital of Medical College, Kunming
Kunming, 650032
The First Affiliated Hospital of Lanzhou University
Lanzhou, 730000
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Institute of Hematol., Union Hospital, Tongji Med. College
Wuhan, 430022
Second Hospital of Xian Jiaotong University
Xi'an, 710004
Hospital of Chengdu Military Area Command, Kunming
Yunnan, 650032
India6 sites
Dr. R. K. Jain Clinic
Bhopal, 462016
Choithram Hospital and Research Centre
Indore, 452014
St. John's Medical College Hospital, Banglaore
Karna, 560034
Apollo Gleneagles Hospital
Kolkata, 700054
TNMC and BYL Nair Charitable Hospital
Mumbai, 400008
Maulana Azad Medical College & LNJP Hospital
New Delhi, 110002
Russia6 sites
Central Research Institute for Epidemiology of Rospotrebnadz
Moscow, 11123
Russian State Medical University
Moscow, 117049
Research Center of Children's Health
Moscow, 119991
Saint- Petersburg State Mtchnikov's Medical Academy
Saint Petersburg, 194100
Research Institute for Infectious Childhood Diseases
Saint Petersburg, 197022
Smolensk State Medical Academy
Smolensk, 214019
Spain6 sites
Hospital Universitario San Cecilio, Granada
Andalucía, 18012
Hospital Sant Joan de Deu, Barcelona
Cataluña, 08950
Hospital Carlos III
Madrid, 28029
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario de Getafe
Madrid, 28905
Hospital Universitario La Fe
Valencia, 46009
United States5 sites
The Children's Hospital
Aurora, Colorado, 80045
Saint Vincent Healthcare Pediatric Specialty Clinics
Billings, Montana, 59101
Children's Hospital Boston
Boston, Massachusetts, 02115
Shands Hospital at University of Florida
Gainesville, Florida, 32610
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Brazil5 sites
Hospital de Clínicas de Porto Alegre, Porto
Alegre, 90035-903
Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia
Belém, 66035-080
Hospital Oswaldo Cruz - Universidade de Pernambuco
Recife, 50100-130
Instituto da Criança - HC FMUSP
São Paulo, 05403-900
Universidade de Campinas, Campinas
São Paulo, 13083-887
Greece5 sites
Peripheral University General Hospital of Alexandroupoli
Alexandroupoli, 68100
"Agia Sofia" Childrens Hospital of Athens
Athens, 11527
IASO Children's Hospital
Athens, 15123
University General Hospital of Heraklion, Heraklion
Crete, 71110
Childrens' General Hospital of Athens 'P&A Kyriakou'
Goudi, 11527
Italy5 sites
Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi
Bologna, 40138
Istituto G. Gaslini Ospedale Pediatrico IRCCS
Genova, 16147
Universita degli Studi "Federico II"
Naples, 80131
Azienda Ospedaliero Universitaria Pisana
Pisa, 56123
Ospedale Pediatrico Bambino Gesu
Roma, 00165
United Kingdom5 sites
Birmingham Childrens Hospital
Birmingham, B46NH
St James's University Hospital
Leeds, LS97TF
The Royal London Hospital
London, E12AT
Kings College Hospital
London, SE5 9RS
Queen's Medical Centre
Nottingham, NG72UH
France4 sites
Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux
Aquitaine, 33076
Hôpital Jeanne de Flandre
Lille, 59037
Groupe Hospitalier Necker - Enfants Malades
Paris, 75015
Hôpital de Haute Pierre
Strasbourg, 67098
Philippines4 sites
Research Institute for Tropical Medicine
City of Muntinlupa, 1781
Philippine General Hospital
Ermita, 1000
Philippine Children's Medical Center
Quezon City, 1100
National Kidney and Transplant Institute
Quezon City, 1104
Taiwan4 sites
Chung Shan Medical University Hospital
Taichung, 402
Taichung Veteran's General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100
Cathay General Hospital
Taipei, 10650
Peru3 sites
Hospital Nacional Edgardo Rebagliati Martins
Lima, 11
Hospital Nacional G A Yrigoyen
Lima, 13
Instituto Nacional de Salud del Niño
Lima, LI33
Poland3 sites
Wojewodzki Spital Bydgoszcz
Bydgoszcz, 85-030
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
Romania3 sites
"Matei Bals" Institute of Infectious Diseases
Bucharest, 021105
Fundeni Clinical Institute
Bucharest, 022328
V. Babes Pneumology and Infectious Diseases Clin. Hosp
Craiova, 200515
Singapore2 sites
National University of Singapore
Singapore, 119074
KK Women's and Children's Hospital
Singapore, 229899
Thailand2 sites
Ramathibodi Hospital
Bangkok, 10400
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, 50200
Argentina1 site
Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal
Buenos Aires, C1425EFD
About this study
Official title: A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B
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.
- Conditions
- Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepatitis, Virus Diseases, Digestive System Diseases
- Keywords
- hepatitis B, HBV, chronic hepatitis B, pediatric
- Medical subject headings
- Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepatitis, Virus Diseases, Digestive System Diseases, Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163240
- Sponsor's protocol ID
- CLDT600A2414
- Acronym
- EPIC B
- Status last verified
- Sep 2011
- First submitted
- 14 Jul 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01163240
- Acronym / sponsor ID
- EPIC B / CLDT600A2414
- Conditions
- Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepatitis, Virus Diseases, Digestive System Diseases
- Keywords
- hepatitis B, HBV, chronic hepatitis B, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,640 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric | – | – |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Male or female, 2 to less than 18 years of age.
- Documented chronic hepatitis B defined by all of the following:
Key exclusion criteria (2 listed)
- Patients ≥ 18 years of age
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 2 yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmceuticals study director
Novartis Pharmaceuticals
86 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Hepatitis, Chronic, run by Novartis Pharmaceuticals at 86 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in China, India, Russia, Spain, United States and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.