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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01163240
First received: July 14, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1640
Study Start Date: June 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163240

  Show 86 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01163240     History of Changes
Other Study ID Numbers: CLDT600A2414
Study First Received: July 14, 2010
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Committee of Ethics in Research
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Greece: Ministry of Health and Welfare
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Novartis:
hepatitis B
HBV
chronic hepatitis B
pediatric

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis B, Chronic
Digestive System Diseases
Gastrointestinal Diseases
DNA Virus Infections
Liver Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on August 28, 2014