Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 person with Crohn's Disease that does not receive growth hormone drug.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Genentech, Inc.
• Treatments: Hormones; Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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