Dettagli per singolo studio

DEC-NET Serial number GB258

Published online	29/06/2004 13.53.00
Last updated	22/11/2005 9.59.06

Other protocol ID number	N0012120161
This trial has been approved by an ethics committee
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
First subject enrolment Target N. of subjects	07/2002 N/A
Major Disease (ICD9 class)	CONGENITAL FACTOR VIII DISORDER
Experimental drug
COAGULATION FACTOR VIII Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	2 -18 years
Eligibility criteria
Inclusion criteria
Children with severe haemophilia A
Exclusion criteria
Informed consent for trial not been given
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Cohort Observation
Purpose of study
A licensed 2nd generation recombinant factor VIII - is used to prepare a new 3rd generation product. Study objectives are to characterise the safety & efficacy of this 3rd generation product
Primary outcomes
If this 3rd generation product proves to be as safe & efficacious as the current formulation for children then treatment in the future will be an advance in the treatment of newly diganosed & other children with haemohphilia A


Summary of study design, objectives, and ongoing research findings
Cohort observation. A licensed 2nd generation recombinant factor VIII - is used to prepare a new 3rd generation product. Study objectives are to characterise the safety & efficacy of this 3rd generation product. If this 3rd generation product proves to be as safe & efficacious as the current formulation for children then treatment in the future will be an advance in the treatment of newly diganosed & other children with haemophilia A