Epidemiological Study in Children and Adolescents With Chronic Hepatitis B (EPIC B)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
| Groups/Cohorts |
|---|
| pediatric |
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and Locations
Show 86 Study Locations| 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:
|
Digestive System Diseases Gastrointestinal Diseases DNA Virus Infections Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human |
Liver Diseases Virus Diseases Hepatitis B, Chronic Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
ClinicalTrials.gov processed this record on June 18, 2013