Effect of Increlex® on Children With Crohn Disease

NCT00764699 | Terminated Phase 2 Results

• 1 other identifier: IRB08-00213
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease

Keywords

poor growth; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity

  Six months and 1 year

Study Arms (1)

rhIGF

EXPERIMENTAL

Treatment with rhIGF (Increlex)

Drug: rhIGF (Increlex)

Interventions

rhIGF (Increlex) DRUG

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.

Also known as: Increlex

rhIGF

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Identified infectious etiology
• Immunological disorder (excluding Crohn disease)
• Associated severe concomitant chronic illnesses (CF, liver failure, etc)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Tercica: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (4)

• Cezard JP, Touati G, Alberti C, Hugot JP, Brinon C, Czernichow P. Growth in paediatric Crohn's disease. Horm Res. 2002;58 Suppl 1:11-5. doi: 10.1159/000064759.

  PMID: 12373007 BACKGROUND

• Sentongo TA, Semeao EJ, Piccoli DA, Stallings VA, Zemel BS. Growth, body composition, and nutritional status in children and adolescents with Crohn's disease. J Pediatr Gastroenterol Nutr. 2000 Jul;31(1):33-40. doi: 10.1097/00005176-200007000-00009.

  PMID: 10896068 BACKGROUND

• Hardin DS, Rice J, Doyle ME, Pavia A. Growth hormone improves protein catabolism and growth in prepubertal children with HIV infection. Clin Endocrinol (Oxf). 2005 Sep;63(3):259-62. doi: 10.1111/j.1365-2265.2005.02331.x.

  PMID: 16117811 BACKGROUND

• Mauras N, George D, Evans J, Milov D, Abrams S, Rini A, Welch S, Haymond MW. Growth hormone has anabolic effects in glucocorticosteroid-dependent children with inflammatory bowel disease: a pilot study. Metabolism. 2002 Jan;51(1):127-35. doi: 10.1053/meta.2002.28972.

  PMID: 11782884 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

mecasermin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Julie Rice, RN
• Organization: Nationwide Children's Hospital

julie.rice@nationwidechildrens.org

6143553142

Study Officials

• Dana S. Hardin, MD

  The Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 2, 2018
• Results First Posted: March 2, 2018

Record last verified: 2018-02

Locations

US (1)