Offered by: Nemours
Location: Pensacola and Jacksonville in Florida
Open-Label, Long-Term Safety Study of a Longacting HGH Somavaratan in Children With GHD
What is the trial about?
The purpose of this study is to show how well somavaratan will help children with a growth hormone deficiency to grow and to determine how safe and tolerable somavaratan is when given to children over time.
Who can participate?
Children who are participating in a previous somavaratan study (Versartis study 14VR4) can be in this study, once they have completed the 14VR4 study. In addition, children with growth hormone deficiency who have not started puberty can be in the study.
What is involved?
Participants will continue in the study and continue to receive somavaratan treatment as long as treatment is clinically indicated, until the product is commercially available, or until the study is discontinued by the sponsor. Study visits will occur every three months until the drug is FDA approved, the subject withdraws or the study is discontinued by the sponsor.
During each visit subjects will undergo: physical exam (full or brief), blood draws, provide urine sample, vital signs, height and weight measurement. All subjects will have annual bone age xrays. Subjects who have not previously been on somavaratan will have ECG's during screening or day one and again at month three. A limited eye exam will be performed on a subject if clinically indicated during any visit.
Contact Nemours Clinical Trials
Trial Name: Open-Label, Long-Term Safety Study of a Longacting HGH Somavaratan in Children With GHD