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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03145831
Study type Interventional
Source Versartis Inc.
Contact
Status Terminated
Phase Phase 3
Start date March 31, 2017
Completion date November 30, 2017
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