Growth failure in children with Crohn's disease
Conditions
Interventions
Trade Name: Increlex
Product Name: Increlex 10mg/ml solution for injection
Pharmaceutical Form: Solution for injection
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 25 mm/hr or C-reactive protein: > 10 mg/l or Both ESR >25mm/hr and CRP >10mg/l Stool alpha-1-antitrypsin concentration: 6mo: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed