Effect of Increlex® on Children With Crohn Disease

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: Tercica
• Treatments: Mecasermin

Criteria

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)