Epidemiological Study in Children and Adolescents With Chronic Hepatitis B (EPIC B)

September 26, 2011 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425EFD
        • Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal
  • Brazil
      • Alegre, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre, Porto
      • Belém, Brazil, 66035-080
        • Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia
      • Recife, Brazil, 50100-130
        • Hospital Oswaldo Cruz - Universidade de Pernambuco
      • São Paulo, Brazil, 05403-900
        • Instituto da Criança - HC FMUSP
      • São Paulo, Brazil, 13083-887
        • Universidade de Campinas, Campinas
  • China
      • Beijing, China, 100069
        • Beijing You'an Hosptial
      • Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Med. University
      • Chongqing, China, 400038
        • 1st Affliated Hospital of 3rd Military Med. Univ. of PLA
      • Hebei, China, 050051
        • Hebei Medical University The Third Hospital, Shijiazhuang
      • Henan, China, 450052
        • Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • Queen Mary Hospital
      • Hunan, China, 410011
        • The Second Xiangya Hospital, Changsha
      • Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University, Changsha
      • Jiangsu, China, 210029
        • Jiangsu Province Hospital, Nanjing
      • Jilin, China, 130021
        • First Hospital University of Jilin, Changchun
      • Kunming, China, 650032
        • The First Affiliated Hospital of Medical College, Kunming
      • Lanzhou, China, 730000
        • The First Affiliated Hospital of Lanzhou University
      • Suzhou, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Wuhan, China, 430022
        • Institute of Hematol., Union Hospital, Tongji Med. College
      • Xi'an, China, 710004
        • Second Hospital of Xian Jiaotong University
      • Yunnan, China, 650032
        • Hospital of Chengdu Military Area Command, Kunming
  • France
      • Aquitaine, France, 33076
        • Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux
      • Lille, France, 59037
        • Hôpital Jeanne de Flandre
      • Paris, France, 75015
        • Groupe Hospitalier Necker - Enfants Malades
      • Strasbourg, France, 67098
        • Hôpital de Haute Pierre
  • Greece
      • Alexandroupolis, Greece, 68100
        • Peripheral University General Hospital of Alexandroupoli
      • Athens, Greece, 11527
        • "Agia Sofia" Childrens Hospital of Athens
      • Athens, Greece, 15123
        • IASO Children's Hospital
      • Crete, Greece, 71110
        • University General Hospital of Heraklion, Heraklion
      • Goudi, Greece, 11527
        • Childrens' General Hospital of Athens 'P&A Kyriakou'
  • India
      • Bhopal, India, 462016
        • Dr. R. K. Jain Clinic
      • Indore, India, 452014
        • Choithram Hospital and Research Centre
      • Karna, India, 560034
        • St. John's Medical College Hospital, Banglaore
      • Kolkata, India, 700054
        • Apollo Gleneagles Hospital
      • Mumbai, India, 400008
        • TNMC and BYL Nair Charitable Hospital
      • New Delhi, India, 110002
        • Maulana Azad Medical College & LNJP Hospital
  • Italy
      • Bologna, Italy, 40138
        • Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi
      • Genova, Italy, 16147
        • Istituto G. Gaslini Ospedale Pediatrico IRCCS
      • Napoli, Italy, 80131
        • Universita degli Studi "Federico II"
      • Pisa, Italy, 56123
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00165
        • Ospedale Pediatrico Bambino Gesu
  • Peru
      • Lima, Peru, 11
        • Hospital Nacional Edgardo Rebagliati Martins
      • Lima, Peru, 13
        • Hospital Nacional G A Yrigoyen
      • Lima, Peru, LI33
        • Instituto Nacional de Salud del Nino
  • Philippines
      • Ermita, Philippines, 1000
        • Philippine General Hospital
      • Muntinlupa City, Philippines, 1781
        • Research Institute For Tropical Medicine
      • Quezon City, Philippines, 1100
        • Philippine Children's Medical Center
      • Quezon City, Philippines, 1104
        • National Kidney and Transplant Institute
  • Poland
      • Bydgoszcz, Poland, 85-030
        • Wojewodzki Spital Bydgoszcz
      • Krakow, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Lodz, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki
  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute
      • Bucharest, Romania, 021105
        • "Matei Bals" Institute of Infectious Diseases
      • Craiova, Romania, 200515
        • V. Babes Pneumology and Infectious Diseases Clin. Hosp
  • Russian Federation
      • Moscow, Russian Federation, 117049
        • Russian State Medical University
      • Moscow, Russian Federation, 11123
        • Central Research Institute for Epidemiology of Rospotrebnadz
      • Moscow, Russian Federation, 119991
        • Research Center of Children's Health
      • Saint Petersburg, Russian Federation, 194100
        • Saint- Petersburg State Mtchnikov's Medical Academy
      • Smolensk, Russian Federation, 214019
        • Smolensk State Medical Academy
      • St. Petersburg, Russian Federation, 197022
        • Research Institute for Infectious Childhood Diseases
  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital
      • Singapore, Singapore, 119074
        • National University of Singapore
  • Spain
      • Andalucía, Spain, 18012
        • Hospital Universitario San Cecilio, Granada
      • Cataluña, Spain, 08950
        • Hospital Sant Joan de Deu, Barcelona
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28029
        • Hospital Carlos III
      • Madrid, Spain, 28905
        • Hospital Universitario de Getafe
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe
  • Taiwan
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veteran's General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10650
        • Cathay General Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiangmai Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B46NH
        • Birmingham Childrens Hospital
      • Leeds, United Kingdom, LS97TF
        • St James's University Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, E12AT
        • The Royal London Hospital
      • Nottingham, United Kingdom, NG72UH
        • Queen's Medical Centre
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • The Children's Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at University of Florida
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • Montana
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare Pediatric Specialty Clinics
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
pediatric

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: 2 yrs
2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLDT600A2414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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