跳至主要内容
临床试验/NCT00150319
NCT00150319终止1 期

An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend®; I.V. In Subjects With Moderately Impaired Renal Function

Pfizer6 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2005年6月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
终止
发起方
Pfizer
入组人数
1
试验地点
6
主要终点
Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency

研究概览

简要总结

This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

详细描述

The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with moderate renal insufficiency

排除标准

  • •Active infection

结局指标

主要结局

Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (6)

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