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 childre
- Conditions
- Growth failure in children with Crohn's disease
- Registration Number
- EUCTR2007-004269-16-GB
- Lead Sponsor
- Queen Mary, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
or
C-reactive protein: > 10 mg/l
or
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
or
C-reactive protein: > 10 mg/l
or
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is the concentration in the blood of IGF-I, when given to children with Crohn's disease, similar to that which we would expect (from its licensed used in children with primary IGF-I deficiency)?;Secondary Objective: A proportion of children with Crohn's disease lose protein from their intestine. This is known as Protein losing enteropathy. We wish to discover if the degree of protein losing enteropathy affects the blood levels of IGF-I after IGF-I treatment.;Primary end point(s): Blood concentration profile of IGF-I; IGFBP-3 and glucose
- Secondary Outcome Measures
Name Time Method