Clinical Trial: A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief Summary: This study is a multi-center, open-label safety study assessing long-term somavaratan administration.
Detailed Summary: 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.
Sponsor: Versartis Inc.
Current Primary Outcome: Adverse Events [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Height velocity [ Time Frame: 12 months ]Comparison of Height Velocity (HV) and HV-SDS before and after switching therapy
- IGF-I expression [ Time Frame: 12 months ]Change from Day 1
- Immunogenicity [ Time Frame: 12 months ]Evaluated by anti-drug antibody response
Original Secondary Outcome: Same as current
Information By: Versartis Inc.
Dates:
Date Received: April 5, 2017
Date Started: March 31, 2017
Date Completion: January 31, 2020
Last Updated: May 8, 2017
Last Verified: May 2017