Last updated on February 2018

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


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT03145831

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Yuji Hoshino, MD

University of Miyazaki Hospital
Miyazaki, Japan
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