Status:
COMPLETED
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Liver Diseases
Hepatitis, Chronic
Eligibility:
All Genders
2-18 years
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 A...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1640 Patients enrolled
Trial Details
Trial ID
NCT01163240
Start Date
June 1 2009
Last Update
September 27 2011
Active Locations (86)
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1
The Children's Hospital
Aurora, Colorado, United States, 80045
2
Shands Hospital at University of Florida
Gainesville, Florida, United States, 32610
3
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
4
Saint Vincent Healthcare Pediatric Specialty Clinics
Billings, Montana, United States, 59101