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临床试验/NCT01984554
NCT01984554已完成不适用

Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

American Regent, Inc.1 个研究点 分布在 1 个国家目标入组 551 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
551
试验地点
1
主要终点
Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).

研究概览

简要总结

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

详细描述

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must present for the first dose of a current cycle of IV treatment for IDA
  • Must be over 18 years of age
  • Must be willing and able to provide informed consent, including permission to obtain information from their medical records.
  • Must be able to read and understand English.

排除标准

  • Subjects not diagnosed with IDA.
  • Subjects requiring more than one treatment cycle within 30 days.
  • Subjects receiving maintenance IV iron therapy.
  • Subjects treated with IV iron within the 30-day period prior to study enrollment.
  • Subjects who received investigational medication in the six months prior to the study.

结局指标

主要结局

Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).

时间窗: 30 day observation period

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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