跳至主要内容
临床试验/EUCTR2013-004642-41-GB
EUCTR2013-004642-41-GB进行中(未招募)不适用

Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Prospective study of understudied drugs in children

niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 2,000 人开始时间: 2015年7月15日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1) Children and young people (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 1306
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 175
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • 1) Failure to obtain consent/assent
  • 2) Know pregnacy as determined via interview or testing if available
  • 3) If a child, who is capable of assenting, does not give their assent, even if their parent does give their consent
  • 4) Aged 16 or over with mental health issues

研究者

发起方
niversity Hospital Southampton NHS Foundation Trust

相似试验

进行中(未招募)
不适用
A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2Bvon Willebrand Disease type 2B
EUCTR2008-008532-82-ATMedical University of Vienna, Dept. of Clinical Pharmacology
进行中(未招募)
1 期
Study to Investigate the product Wilate in Patients with Severe Hemophilia ASevere hemophilia A (<1% FVIII:C)MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850
EUCTR2016-003681-34-PLOctapharma AG55
进行中(未招募)
1 期
Study to Investigate the product Wilate in Patients with Severe Hemophilia ASevere hemophilia A (<1% FVIII:C)MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850
EUCTR2016-003681-34-BGOctapharma AG55
进行中(未招募)
1 期
Study to Investigate the product Wilate in Patients with Severe Hemophilia ASevere hemophilia A (<1% FVIII:C)MedDRA version: 19.1Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850
EUCTR2016-003681-34-HUOctapharma AG55
进行中(未招募)
不适用
To determine the pharmacokinetics of human-cl rhFVIII in terms of the FVIII coagulant activity (FVIII:C) and to compare it with the licensed FVIII concentrate Kogenate/Helixate in previously treated subjects suffering from severe hemophilia A.
EUCTR2008-001563-11-BGOctapharma AG22