Trial record 9 of 232 for:    Open Studies | "Crohn Disease"

Effect of Increlex® on Children With Crohn Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Nationwide Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tercica
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00764699
First received: October 1, 2008
Last updated: July 24, 2009
Last verified: July 2009
  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

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764699

Contacts
Contact: Julie Rice, BSN, RN 614-355-3142 julie.rice@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Tercica
Investigators
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 July 28, 2014