Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s - Version 1

• Research type

  Research Study

• Full title

  A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease

• IRAS ID

  61408

• Eudract number

  2010-022215-19

• Research summary

  Optimal growth and anabolic effects of GH depend on systemic and local effects of two vital hormones - GH and IGF-1. IGF-1 is produced by GH stimulation of cells in number of different organs in the body. Many children with a variety of chronic diseases grow poorly and this may be due a lack of GH and/or IGF-1. Recent studies by our group show a clear benefit of GH therapy on growth in children with inflammatory bowel disease (IBD).However, this improvement is accompanied by an impairment of insulin sensitivity. Addition of IGF-I might reverse this trend whilst improving growth outcome. This proposal discusses the rationale for this programme and provides a detailed work plan for initial studies that will investigate the pharmacokinetic profile of combined injection of GH and IGF1 in children with Crohn's Disease, the form of IBD that's most commonly associated with poor growth. The pharmacokinetic trial would involve comparison of three regimens of therapy - GH alone, GH and IGF-1 at a low dose and GH and IGF-1 at a higher dose. The data gathered from this study shall form the basis of a larger, multicentre clinical efficacy trial that would eventually lead to a firm case for the use of combined therapy in children with growth retardation and this chronic inflammatory disease.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  11/AL/0211

• Date of REC Opinion

  8 Jun 2011

• REC opinion

  Further Information Favourable Opinion