Versartis Long-Term Safety Study of Somavaratan

Phase 2

Terminated

• Conditions: Pediatric Growth Hormone Deficiency
• Interventions: Drug: somavaratan

• Registration Number: NCT02068521
• Lead Sponsor: Versartis Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Study Start: 2014-03-03
• Primary Completion: 2017-11-17
• Study Completion: 2017-11-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment naive subjects with GHD	somavaratan	Up to 100 new treatment naïve subjects with GHD will receive somavaratan 3.5mg/kg twice monthly.
Subjects who have completed a somavaratan study	somavaratan	All subjects after participation in (12VR2) or participation in the 14VR4 protocols have the option to receive somavaratan 3.5mg/kg twice monthly.

Primary Outcome Measures

Name	Time	Method
Safety	Up to 4 years	Safety assessments include recording of adverse events and concomitant medications, monitoring of injection sites, vital signs and clinical laboratory determinations.