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腫瘍誘発性骨軟化症または表皮母斑症候群の被験者におけるKRN23の研究
基本情報
- NCT ID
- NCT02722798
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 14
- 治験依頼者名
- Kyowa Kirin Co., Ltd.
概要
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 after its 144-week once every 4 weeks (Q4W) repeated SC administration to Japanese and Korean patients with TIO or ENS by a multicenter, open-label, intraindividual dose adjustment study. After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continue treatment after the marketing approval of KRN23 in Japan.
対象疾患
Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
介入
KRN23(DRUG)
依頼者(Sponsor)
協和キリン株式会社(INDUSTRY)