Dettagli per singolo studio

DEC-NET Serial number GB253

Published online	24/06/2004 10.59.00
Last updated	22/11/2005 9.57.50

Other protocol ID number	N0045126776
This trial has been approved by an ethics committee
Current trial status	Closed to recruitment of participants: follow-up continuing
First subject enrolment Target N. of subjects	07/2003 284
Major Disease (ICD9 class)	CHRONIC HEPATITIS NEC
Experimental drug
LAMIVUDINE Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	2-18
Eligibility criteria
Inclusion criteria
All patients who were previously enrolled in and completed at least month 24 of Lamivudine treatment in NUC 30926 international study which has a maximum of 284 patients and a potential 18 patients from the Birmingham Children's Hospital site.
Exclusion criteria
Children who were not participants in the Lamivudine study or did not complete at least 24 months
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Observational
Purpose of study
An extended observational study in paediatric patients with chronic hepatitis B who have previously received long-term Lamivudine treatment.
Primary outcomes
Serious adverse events and clinically significant events such as abnormal laboratory values and changes in serological and virologic HBV markers. Subjects who CVR in NUC 30926, durability of that response will be measured.


Summary of study design, objectives, and ongoing research findings
An extended observational study in paediatric patients with chronic hepatitis B who have previously received long-term Lamivudine treatment. Sample group description: All patients who were previously enrolled in and completed at least month 24 of Lamivudine treatment in NUC 30926 international study Outcome measure description: Serious adverse events and clinically significant events such as abnormal laboratory values and changes in serological and virologic HBV markers. Subjects who CVR in NUC 30926, durability of that response will be measured.