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Effect of Increlex® on Children With Crohn Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764699
Recruitment Status : Terminated (PI left institution)
First Posted : October 2, 2008
Results First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Information provided by (Responsible Party):
Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: rhIGF (Increlex) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Increlex® on Children With Crohn Disease
Study Start Date : October 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Mecasermin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764699

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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Principal Investigator: Dana S. Hardin, MD The Research Institute at Nationwide Children's Hospital
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Responsible Party: Nationwide Children's Hospital Identifier: NCT00764699    
Other Study ID Numbers: IRB08-00213
First Posted: October 2, 2008    Key Record Dates
Results First Posted: March 2, 2018
Last Update Posted: March 2, 2018
Last Verified: February 2018
Keywords provided by Nationwide Children's Hospital:
poor growth
inflammatory bowel disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Growth Substances
Physiological Effects of Drugs