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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 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,640 participants.

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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

FieldValue
Enrollment Target 1,640 participants
Start Date 2009-06

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01163240

The ClinicalTrials.gov registry entry for NCT01163240 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01163240 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.