Versartis Long-Term Safety Study of Somavaratan (VISTA)
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|ClinicalTrials.gov Identifier: NCT02068521|
Recruitment Status : Terminated (The primary endpoint of non-inferiority to daily therapy in the pediatric Phase 3 study was not achieved)
First Posted : February 21, 2014
Last Update Posted : March 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Growth Hormone Deficiency||Drug: somavaratan||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||385 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone Deficiency|
|Actual Study Start Date :||March 3, 2014|
|Actual Primary Completion Date :||November 17, 2017|
|Actual Study Completion Date :||November 17, 2017|
Experimental: Treatment naive subjects with GHD
Up to 100 new treatment naïve subjects with GHD will receive somavaratan 3.5mg/kg twice monthly.
Other Name: VRS-317
Experimental: Subjects who have completed a somavaratan study
All subjects after participation in (12VR2) or participation in the 14VR4 protocols have the option to receive somavaratan 3.5mg/kg twice monthly.
Other Name: VRS-317
- Safety [ Time Frame: Up to 4 years ]Safety assessments include recording of adverse events and concomitant medications, monitoring of injection sites, vital signs and clinical laboratory determinations.
- Evaluate the changes in pharmacodynamics (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 [ Time Frame: Up to 4 years ]PK/PD peak and trough measurements will be assessed throughout the study with assessment of plasma VRS-317 concentrations and IGF-I and its binding proteins measured at pre-specified time points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068521
|Study Director:||Will Charlton, MD||Versartis Inc.|