Offered by: Nemours
Location: Pensacola, Orlando and Jacksonville in Florida and in the Delaware Valley
A Phase 3, Efficacy & Safety Study Of Weekly MOD-4023 Compared To Daily Genotropin For GHD Children
What is the trial about?
The purpose of this study is to compare the effectiveness, safety and handling of the investigational drug, a non-approved drug by the FDA, MOD-4023 (weekly injections, dose of 0.66 mg/kg/week) to standard of care treatment with Genotropin® (daily injections, dose of 0.034 mg/kg/day) over one year.
Who can participate?
Girls between 3 years of age and under the age of 11 and boys 3 years of age and under the age of 12 who may have growth hormone deficiency are suitable to take part in this study. All participants need to have a screening visit to make sure they are eligible for this study.
What is involved?
The study takes place during a period of up to 14 months in total. Your child will have 7 to 11 scheduled visits to the clinic, depending on the treatment he/she will receive.
There will be a Growth Hormone Stimulation Test performed on the initial screening visit if your child has never had one done. An IV will be put into place to receive 2 medications and 11 blood draws equaling 6 1/2 tsp of blood. On the second screening visit, your child's height and weight, parent's height, labs (approx 5 tsp), urine collection, hand x-ray, vital signs, physical exam, and head MRI will be obtained. If eligible, there are 8 subsequent visits involving labs, study drugs, vital signs, ECG, x-ray, physical exam, eye exam, and surveys/diary cards.
Contact Nemours Clinical Trials
Trial Name: A Phase 3, Efficacy & Safety Study Of Weekly MOD-4023 Compared To Daily Genotropin For GHD Children