Pharmacokinetic studies of recombinant human insulin-like growth factor-I (rhIGF-I) in children with Crohns disease induced growth retardation
| ISRCTN | ISRCTN81027773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81027773 |
| Clinical Trials Information System (CTIS) | 2007-004269-16 |
| Protocol serial number | 4293 |
| Sponsor | Queen Mary's School of Medicine and Dentistry (UK) |
| Funder | Crohn's and Colitis Foundation of America (CCFA) (USA) |
- 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
Scientific
Institute of Cell and Molecular Science
Medical College
Turner Street
London
E1 2AD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | IGF in Paed Crohns |
| Study objectives | 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(s) | MREC approved on the 19th December 2007 (ref: 07/h0705/77) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Recombinant human insulin-like growth factor-I |
| Primary outcome measure(s) |
IGF-I levels |
| Key secondary outcome measure(s) |
Blood glucose and hormones of the IGF-I axis |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key exclusion criteria | 1. Neoplasia 2. Fused epiphyses 3. Corticosteroids within last 3 months |
| Date of first enrolment | 25/09/2008 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Cell and Molecular Science
London
E1 2AD
United Kingdom
E1 2AD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
