Effect of Increlex® on Children With Crohn Disease
Recruitment status was Recruiting
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Purpose
Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance in chronically ill children, particularly those who require treatment with corticosteroids. Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient short stature. This medication has not been studied in Crohn disease. The purpose of this study is to test the hypothesis that poor growth in Crohn disease is associated abnormal IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test our hypothesis we will recruit 20 patients with Crohn disease from our pediatric gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a minimum of one year and will be studied at baseline and six month intervals for one year while on treatment with Increlex.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn Disease |
Drug: rhIGF (Increlex) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Increlex® on Children With Crohn Disease |
- The primary outcome variable for the monitoring study (baseline, six months and disease exacerbation) will be longitudinal growth as measured by height velocity [ Time Frame: Six months and 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rhIGF
Treatment with rhIGF (Increlex)
|
Drug: rhIGF (Increlex)
rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.
Other Name: Increlex
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 5 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate to severe Crohn Disease (PCDAI > 30)
- Chronological age 5-15 years old
- Tanner 1 - 3
- Bone age less than or equal to 13 in females and 14 in males
Exclusion Criteria:
- Identified infectious etiology
- Immunological disorder (excluding Crohn disease)
- Associated severe concomitant chronic illnesses (CF, liver failure, etc)
Contacts and Locations| Contact: Julie Rice, BSN, RN | 614-355-3142 | julie.rice@nationwidechildrens.org |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Principal Investigator: | Dana S. Hardin, MD | The Research Institute at Nationwide Children's Hospital |
More Information
Publications:
| Responsible Party: | Dana S. Hardin, MD, Associate Professor, The Research Institute at Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00764699 History of Changes |
| Other Study ID Numbers: | IRB08-00213 |
| Study First Received: | October 1, 2008 |
| Last Updated: | July 24, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nationwide Children's Hospital:
|
poor growth inflammatory bowel disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013