A Phase III study of NPC-25 in pediatric patients with hypozincemia (NPC-25-6)

Nobelpharma Co., Ltd.0 个研究点目标入组 32 人开始时间: 2024年12月12日最近更新: 2025年4月10日

试验速览

阶段: 不适用
状态: 招募中
发起方: Nobelpharma Co., Ltd.
入组人数: 32
主要终点: Proportion of participants in whom the target serum zinc concentration is maintained

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 1month old over 至 15age old not（—）

入选标准

•(1) Patients whose serum zinc concentrations (measured at institutions) both at the time of enrollment and within 8 weeks before enrollment are <70 micro g/dL
•(2) Patients aged >=1 month and <15 years weighing <30 kg at the time of enrollment, regardless of sex and inpatient or outpatient status; however, this excludes premature babies less than 1 month of corrected age
•(3) Written consent to participate in this study is obtained from a legally authorized representative and, if the patient is able to understand the content of the study, accompanying written consent or assent is obtained from the patient.

排除标准

•Patients with serum albumin <80% of the institutional lower limit of normal
•Patients who have taken zinc-containing preparations or zinc-containing supplements that are prohibited from being used concomitantly within 8 weeks before enrollment

结局指标

主要结局

Proportion of participants in whom the target serum zinc concentration is maintained

时间窗: 40 weeks after the start of administration

Proportion of participants in whom the target serum zinc concentration (>=80 micro g/dL and <200 micro g/dL) is maintained for 8 weeks at the same dose by 40 weeks after the start of administration

次要结局

Time to first achievement of the target serum zinc concentration
Time to maintenance of the target serum zinc concentration(8 weeks)
Changes in serum zinc concentrations over time

研究者

发起方

Nobelpharma Co., Ltd.

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