Additional identifiers
EudraCT number
2007-004269-16
ClinicalTrials.gov number
Protocol/serial number
4293
Study information
Scientific title
Acronym
IGF in Paed Crohns
Study hypothesis
Growth failure occurs in approximately one third of children with Crohn's disease. Insulin-like growth factor-I (IGF-I) concentrations are depressed in active Crohn's disease, and increase to normal on entering remission with enteral feeding. Growth Hormone concentrations are normal in active disease. The children therefore exhibit a resistance to growth hormones effects.
A proportion of children do not enter remission despite state-of-the-art medications, and some of them continue to fail to grow. Treatment for the growth deficiency caused by low IGF-I activity would offer great benefits in such children.
The treatment for endocrine causes of growth hormone resistance (usually due to growth hormone receptor defects) is subcutaneous IGF-I. Furthermore, injections of human IGF have been shown, in work published from our laboratory, to enhance growth in rats with colitis. An IGF-I preparation is now available to treat children with growth hormone receptor defects, but not other conditions. A detailed understanding of the pharmacokinetics of IGF-I is needed before IGF-I can be considered as a treatment for growth faltering in children with Crohns disease. We hypothesized that subcutaneous IGF-I will increase IGF-I concentrations of children with Crohn's disease associated with low IGF-I, without serious adverse effects. To examine this hypothesis we proposed to study three specific aims:
1. To examine the effect of IGF-I on IGF-I and glucose concentrations in the circulation over 24 hours after administration in children with Crohn's disease
2. To examine the effect of daily IGF-I on IGF-I over the course of 1 week
3. To examine the pharmacokinetics of IGF-I in children with documented protein losing enteropathy
Ethics approval
MREC approved on the 19th December 2007 (ref: 07/h0705/77)
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
Increlex subcutaneously; Study Entry : Registration only
Intervention type
Drug
Phase
Not Applicable
Drug names
Recombinant human insulin-like growth factor-I
Primary outcome measure
IGF-I levels
Secondary outcome measures
Blood glucose and hormones of the IGF-I axis
Overall trial start date
25/09/2008
Overall trial end date
01/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Criteria for aims 1 and 2:
1. Aged greater than 10 years, either sex
2. Height velocity measured over greater than 6 months: less than -2 SDS
3. Erythrocyte sedimentation rate: greater than 25 mm/hr
4. C-reactive protein: greater than 10 mg/l
5. Albumin greater than 40 g/l
6. Stool alpha-1-antitrypsin concentration: less than 2.0 g/l
Criteria for aim 3:
1. Aged greater than 10 years, either sex
2. Height velocity measured over greater than 6 months: less than -2 SDS
3. Erythrocyte sedimentation rate: greater than 25 mm/hr
4. C-reactive protein: greater than 10 mg/l
5. Albumin less than 35 g/l
6. Stool alpha-1-antitrypsin concentration: greater than 2.3 g/l
7. No corticosteroids for 3 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 10; UK Sample Size: 10
Participant exclusion criteria
1. Neoplasia
2. Fused epiphyses
3. Corticosteroids within last 3 months
Recruitment start date
25/09/2008
Recruitment end date
01/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Cell and Molecular Science
London
E1 2AD
United Kingdom
Sponsor information
Organisation
Queen Mary's School of Medicine and Dentistry (UK)
Sponsor details
Turner Street
London
E1 2AD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Crohn's and Colitis Foundation of America (CCFA) (USA)
Alternative name(s)
Crohn's & Colitis Foundation of America, CCFA
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23793696
Publication citations
-
Results
Rao A, Standing JF, Naik S, Savage MO, Sanderson IR, Mathematical modelling to restore circulating IGF-1 concentrations in children with Crohn's disease-induced growth failure: a pharmacokinetic study., BMJ Open, 2013, 3, 5, doi: 10.1136/bmjopen-2013-002737.