Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.
Study of Immunogenicity of Nutropin Administered Daily to Naive Growth Hormone Deficient Children.
What is the trial about?
Some children treated with growth hormone develop antibodies against it, which sometimes makes the children stop responding to it. The purpose of this study is to see if Nutropin AQ v1.1 causes antibodies to form in children more frequently than with Nutropin AQ.
Who can participate?
Children with growth hormone deficiency who have not started puberty and have not previously been treated with growth hormone can be in the study.
What is involved?
During the study, your child will be treated with subcutaneous (under the skin) injections of Nutropin AQ v1.1, using the NuSpin device, every day for 1 year. Nutropin AQ v1.1 will be provided to your child and given at a dose of up to 0.043 mg/kg/day at the baseline (Day 1) visit, and adjusted for a change in body weight or based on an insulin-like growth factor-I (IGF-I) level at the Month 6 study visit, if appropriate. The study involves seven clinic visits. All visits will last about an hour.
7 blood draws (one per visit). 1 bone age X-ray at screening visit.
Contact Nemours Clinical Trials
Trial Name: Nutropin Growth Hormone Study for Pediatric Patients