Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children

Queen Mary, University of London0 个研究点开始时间: 2008年3月26日最近更新: 2012年3月19日

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•The inclusion criteria are those which define a child with Crohn's disease as having severe growth failure. They consist of an accepted measurement of growth failure AND an accepted measure of inflammation.
•Criteria for specific aims #1 and #2:
•Height velocity measured over > 6mo: <-2 SDS
•Erythrocyte sedimentation rate: > 25 mm/hr
•C-reactive protein: > 10 mg/l
•Both ESR >25mm/hr and CRP >10mg/l
•Stool alpha-1-antitrypsin concentration:< 2.3 g/ln
•Specific aim #3. The criteria for this aim establish that the child has protein losing enteropathy.
•Height velocity measured over > 6mo: <-2 SDS
•Erythrocyte sedimentation rate: > 25 mm/hr
•C-reactive protein: > 10 mg/l
•Both ESR>25mm/hr and CRP >10mg/l
•Stool alpha-1-antitrypsin concentration: > 2.3 g/l
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Children under 10 years.
•2) No corticosteroids for 3 months in either group.
•Justification: 1) Crohn's disease is rare under 8 years, and it takes over a year to doucment that growth retardation is unresponsive to anti-inflammatory medications. 2) Corticosteroids, used in the treatment of Crohn's disease, have an independent growth-retarding effect on children.
•3) Active or suspected neoplasia
•4) Know hypersensitivity to Increlex
•5) Children with closed epiphyses

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