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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)