The Versartis Long-Term Safety Study of Somavaratan (VISTA) is a multi-center, open-label study assessing long-term somavaratan administration. It is open to pediatric patients completing a somavaratan study in growth hormone deficiency (GHD), as well as new pediatric patients with GHD. All patients will receive somavaratan 3.5 mg/kg twice-monthly.
VISTA is currently enrolling pediatric patients with GHD in the United States and Europe.
The trial is being conducted in the United States, Canada and Europe.
The VISTA trial will evaluate the safety of patients being treated with somavaratan for pediatric GHD. Safety will be monitored by physical examination, inspection of injection sites, vital signs, clinical laboratory determinations (including fasting glucose, insulin and lipids), 12-lead ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan), PK/PD assessments and immunogenicity assessments. Adverse events (AEs) and concomitant medications will be captured.
Primary Outcome Measures:
Safety (adverse events and concomitant medications, monitoring of injection sites, vital signs and clinical laboratory determinations)
Secondary Outcome Measures:
Evaluate the changes in pharmacodynamic (PD) responses, bone age, weight, height velocity, height standard deviation scores, metabolic parameters, pubertal development and anti-drug antibody responses during long-term somavaratan treatment
For more details visit: https://clinicaltrials.gov/ct2/show/NCT02068521