Status:
TERMINATED
Effect of Increlex® on Children With Crohn Disease
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Tercica
Conditions:
Crohn Disease
Eligibility:
All Genders
5-15 years
Phase:
PHASE2
PHASE3
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 ha...
Detailed Description
1. Subjects. We will recruit 20 established Crohn patients from our gastroenterology (GI) referral practice at Nationwide Children's Hospital in Columbus, Ohio. Each will have previously undergone a c...
Eligibility Criteria
Inclusion
- 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
- Identified infectious etiology
- Immunological disorder (excluding Crohn disease)
- Associated severe concomitant chronic illnesses (CF, liver failure, etc)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00764699
Start Date
October 1 2008
End Date
May 1 2010
Last Update
March 2 2018
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205