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成長ホルモン欠乏症の成人患者を対象に、週1回投与のロナペグソマトロピンとプラセボおよび毎日投与のソマトロピン製剤の有効性および安全性を比較する臨床試験
基本情報
- NCT ID
- NCT04615273
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 264
- 治験依頼者名
- Ascendis Pharma A/S
概要
A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.
対象疾患
Growth Hormone DeficiencyEndocrine System DiseasesHormone Deficiency
介入
Lonapegsomatropin(DRUG)
Placebo(OTHER)
Somatropin(DRUG)
依頼者(Sponsor)
Ascendis Pharma Endocrinology Division(INDUSTRY)