NCT02068521

Versartis Long-Term Safety Study of Somavaratan

An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone Deficiency

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Versartis Inc. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Protocol 13VR3 is a multi-center, open-label study assessing long-term somavaratan administration. It is open to subjects completing a somavaratan study in children with growth hormone deficiency (GHD), as well as up to 100 new treatment naïve subjects with GHD. All subjects will receive somavaratan 3.5 mg/kg twice monthly. The study will be conducted at approximately 70 Pediatric Endocrinology centers in the United States, Canada, and Europe.

Conditions

• Pediatric Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	somavaratan	Subcutaneous injection

Timeline

• Start date: 2014-03-03
• Primary completion: 2017-11-17
• Completion: 2017-11-17
• First posted: 2014-02-21
• Last updated: 2018-03-09