Status:
COMPLETED
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a perso...
Detailed Description
The optimal treatment goals in childhood CD include: 1) clinical remission in conjunction with mucosal healing and 2) restoration of normal growth and development. Current therapy in most cases includ...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent
- Age ≥ 5 years.
- Diagnosis of Crohn's disease (CD) with ileo-colonic involvement as determined by standard clinical, radiological, and pathological criteria.
- Moderate to severely active CD as defined by a PCDAI (Pediatric Crohn's Disease Activity Index) ≥ 30.
- Currently taking Prednisone or Budesonide at starting dose (not tapering)
- May continue stable doses of AZA/6-MP, methotrexate, and/or mesalamine at entry.
- For the 52 week extension, baseline bone age ≤ 12 years for girls and ≤ 13 years for boys.
- For the 52 week extension phase, remission or mild Crohn's disease as determined by a PCDAI \< 30.
Exclusion
- Acute critical illness
- Active neoplasia
- Diabetes mellitus
- History of intracranial lesion and/or neoplasia
- Severe disease requiring hospitalization for treatment
- Current therapy with infliximab as this may independently rapidly reduce clinical disease activity and promote mucosal healing
- Use of prednisone or budesonide and in tapering phase
- Family history of colorectal cancer before age 50
- Personal or familial history of familial polyposis syndrome
- Pregnancy (positive pregnancy test) prior to randomization
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial other than the Pediatric IBD (Inflammatory Bowel Disease) registry
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00109473
Start Date
April 1 2005
End Date
August 1 2009
Last Update
October 30 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229