NCT02339090

Long-Acting Growth Hormone in Children Compared to Daily rhGH

Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Versartis Inc. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

Detailed description

This study is designed as a pivotal study to compare the safety and efficacy of a selected dose regimen of somavaratan to daily rhGH. The study is a randomized, multi-center, open label study of 12 months duration. The primary endpoint is height velocity at 12 months.

Conditions

• Growth Disorders

Interventions

Type	Name	Description
DRUG	Somavaratan	Somavaratan will be administered per dose and schedule specified in the arm description.
DRUG	rhGH	rhGH will be administered per dose and schedule specified in the arm description.

Timeline

• Start date: 2015-08-26
• Primary completion: 2017-08-23
• Completion: 2017-08-23
• First posted: 2015-01-15
• Last updated: 2022-12-30
• Results posted: 2022-12-30