NCT03145831

A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Versartis Inc. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open-label safety study assessing long-term somavaratan administration.

Detailed description

This study is a multi-center, open-label safety study assessing long-term somavaratan administration. It is open to subjects completing a somavaratan Japanese Phase 2/3 study (Protocol J14VR5) in children with growth hormone deficiency (GHD), as well as approximately 20 new children currently receiving daily rhGH therapy for GHD (switch subjects). For switch subjects, the first dose of somavaratan will be administered approximately 48 hours after the last dose of the daily rhGH. All subjects will receive somavaratan 3.5mg/kg twice-monthly. The study will be conducted at approximately 40 medical institutions in Japan.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Somavaratan	All subjects will receive somavaratan 3.5 mg/kg twice monthly (every 15 days ± 2 days). Administered as a subcutaneous bolus injection.

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-11-30
• Completion: 2017-11-30
• First posted: 2017-05-09
• Last updated: 2018-03-09

Locations

1 site across 1 country: United States