Effect of recombinant growth hormone on growth and chondrocyte dynamics in children with Inflammatory bowel disease (IBD) and growth failure. - rhGH in IBD

Royal Hospital For Sick Children, Yorkhill Division0 sites60 target enrollmentFebruary 17, 2005

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2005

End Date

February 28, 2011

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Royal Hospital For Sick Children, Yorkhill Division

•Diagnosis of IBD
•Height Velocity SDS of less than –0\.5 over 6 months prior to study.
•Patients of all ages will be eligible but boys and girls with significant pubertal delay shall only be eligible after a period of treatment with sex steroids
•Written informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Previous treatment with rhGH
•Diabetes mellitus or history of significant glucose intolerance (fasting blood glucose\>5\.5mmol/l)
•Endocrinopathy other than GHD
•Bowel surgery within last 6 months
•Active malignancy
•Ongoing anti\-cancer therapy
•Benign intracranial hypertension.
•Severe arterial hypertension, defined as diastolic blood pressure \> 110 mmHg with or without antihypertensive treatment.
•Known or suspected allergy to the trial product or related products.
•Lactation/pregnancy or intent to become pregnant during the planned trial period.