Dettagli per singolo studio

DEC-NET Serial number GB440

Published online	04/07/2005 15.51.00
Last updated	01/08/2005 12.44.23


This trial has been approved by an ethics committee
Current trial status	Closed to recruitment of participants: follow-up continuing
Target N. of subjects	N/A
Major Disease (ICD9 class)	DWARFISM NOT ELSEWHERE CLASSIFIED
Experimental drug
Somatokine Treatment regimen (dosage and duration) not given
Gender	Both
Age (range)	8-16
Eligibility criteria
Inclusion criteria
Prebuteral children with growth hormone insensitivity syndrome
Exclusion criteria
Children having started puberty
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety
Design	Controlled
Purpose of study
This study is intended to evaluate the ability of rhIGF-1GFBP-3 to demonstrate the change from baseline in height velocity in pre-pubertal children with growth hormone insensitivity syndrome and to evaluate the safety profile of extended treatment with rhIGF-1/GFBP-3.
Primary outcomes
Primary efficacy measure -change in height velocity from baseline
Secondary outcomes
Secondary efficacy/safety measures - changes from baseline in auxology 9standing/sitting height, and head circumference); pubertal stage; bone age; mass index; safety and tolerability
Summary of study design, objectives, and ongoing research findings
This study is an open-label, multi-center clinical trial to evaluate the safety and efficacy of insulin-like growth factor 1 / insulin-like growth factor binding protein-3 (rhIGF -1 / GFBP-3) administered for 12 months in children and adolescents with growth hormone insensitivity syndrome such as Laron syndrome.