Offered by: Nemours
Location: Jacksonville, Fla. and Pensacola, Fla.
Open-Label Safety, Tolerability, Efficacy Trial of Weekly TransCon hGH vs. Daily hGH for GHD Children
What is the trial about?
The purpose of this study is to compare the effect of weekly TransCon hGH to daily growth hormone (the standard treatment), and to evaluate the safety and efficacy of weekly TransCon hGH in children.
Who can participate?
Children who are prepubertal, diagnosed with growth hormone deficiency and have not been treated can be enrolled if their screening exams and labs are within study limits.
What is involved?
The study involves 7 clinic visits over a 14 month period. There will be a 5 week screening period, followed by 52 weeks of treatment with visits at Week 1, 5, 13, 26, 39, and 52.
During screening, a subject will undergo (if not previously completed) an MRI of the brain, GH-stimulation testing and an X-ray of the left hand and wrist. They will also have an ECG and blood draw. Throughout the treatment period, a subject will have 6 blood draws, 2 ECG's and 1 X-ray of the left hand and wrist. At each visit, subjects will have a physical exam.
Contact Nemours Clinical Trials
Trial Name: Open-Label Safety, Tolerability, Efficacy Trial of Weekly TransCon hGH vs. Daily hGH for GHD Children