Versartis Long-Term Safety Study of Somavaratan (VISTA)

What is the purpose of this trial?

Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration.

Patients will be monitored for safety throughout their participation in the study. 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. AEs will be coded using CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug dictionary.


Participation Guidelines

Ages: 3 years and older

Gender: Both


Versartis Inc.

Dates: 01/19/2017 - 03/31/2018

Last Updated: 05/24/2017

Study HIC#: 1610018569

Get Involved

For more information about this study, contact:
Novagrami George
203-785-5977
novagrami.george@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigator

Anisha D Patel

Principal Investigator