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NCT01163240 · ClinicalTrials.gov registry record
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 1,640
- Enrollment target
NCT01163240: Completed study, sponsored by Novartis Pharmaceuticals.
NCT01163240 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,640 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163240 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 1,640 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,640 participants |
| Start Date | 2009-06 |
What the finished NCT01163240 record still lists
NCT01163240 is an observational study that tracks outcomes without assigning an intervention. Its 1,640 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01163240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01163240 about?
NCT01163240 is a clinical study titled "Epidemiological Study 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 ...
What is the current status of trial NCT01163240?
This trial is currently completed. The enrollment target is 1,640 participants. The study started on 2009-06.
Who is sponsoring clinical trial NCT01163240?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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