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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01163240
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : September 27, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases Digestive System Diseases Hepatitis B, Chronic Hepatitis B DNA Virus Infections

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Study Type : Observational
Actual Enrollment : 1640 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B
Study Start Date : June 2009
Actual Primary Completion Date : September 2011


Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01163240

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01163240    
Other Study ID Numbers: CLDT600A2414
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hepatitis B
chronic hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Virus Diseases
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
DNA Virus Infections
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections