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Versartis Long-Term Safety Study of Somavaratan

NCT02068521 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2018-03-09

No results posted yet for this study

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.

Conditions

  • Pediatric Growth Hormone Deficiency

Interventions

DRUG

somavaratan

Subcutaneous injection

Sponsors & Collaborators

  • Versartis Inc.

    lead INDUSTRY

Principal Investigators

  • Will Charlton, MD · Versartis Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-03
Primary Completion
2017-11-17
Completion
2017-11-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068521 on ClinicalTrials.gov