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

ISRCTN ISRCTN81027773
DOI https://doi.org/10.1186/ISRCTN81027773
EudraCT/CTIS number 2007-004269-16
Secondary identifying numbers 4293
Submission date
23/04/2010
Registration date
23/04/2010
Last edited
22/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ian Sanderson
Scientific

Institute of Cell and Molecular Science
Medical College
Turner Street
London
E1 2AD
United Kingdom

Study information

Study designNon-randomised interventional treatment trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymIGF in Paed Crohns
Study objectivesGrowth 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 Crohn’s 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(s)MREC approved on the 19th December 2007 (ref: 07/h0705/77)
Health condition(s) or problem(s) studiedTopic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
InterventionIncrelex subcutaneously; Study Entry : Registration only
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Recombinant human insulin-like growth factor-I
Primary outcome measureIGF-I levels
Secondary outcome measuresBlood glucose and hormones of the IGF-I axis
Overall study start date25/09/2008
Completion date01/07/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit10 Years
SexBoth
Target number of participantsPlanned Sample Size: 10; UK Sample Size: 10
Key inclusion criteriaCriteria 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
Key exclusion criteria1. Neoplasia
2. Fused epiphyses
3. Corticosteroids within last 3 months
Date of first enrolment25/09/2008
Date of final enrolment01/07/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Cell and Molecular Science
London
E1 2AD
United Kingdom

Sponsor information

Queen Mary's School of Medicine and Dentistry (UK)
University/education

Turner Street
London
E1 2AD
England
United Kingdom

Website http://www.smd.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Charity

Crohn's and Colitis Foundation of America (CCFA) (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Crohn's & Colitis Foundation of America, CCFA
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 28/05/2013 Yes No