跳至主要内容
临床试验/EUCTR2013-004565-14-DE
EUCTR2013-004565-14-DE进行中(未招募)1 期

Extension Study of XLHED-Affected Male Subjects treated with EDI200 in Protocol ECP-002

Edimer Pharmaceuticals, Inc.0 个研究点目标入组 10 人开始时间: 2014年1月13日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
10

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
Male

入选标准

  • Subjects must meet all of the following criteria to be enrolled:
  • 1.Subject received at least one dose of EDI200 in the neonate study ECP-002
  • 2.Written informed consent of parent(s)
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 10
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Subjects who meet any of the following criteria may not be enrolled in this study:
  • 1.Medically-significant postnatal complications or congenital anomalies outside of those considered to be associated with the diagnosis of XLHED
  • 2.Major protocol violations during enrollment in study ECP-002 as determined by the Sponsor

研究者

相似试验

进行中(未招募)
1 期
Extension Study of XLHED-Affected Male Subjects treated with EDI200 in Protocol ECP-002X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by inherited defects in the ectodysplasin (EDA) gene that disrupt synthesis and/or function of the primary translational product EDA-A1. The absence of normal EDA-A1 expression results in sweat and secretory gland hypoplasia predisposing XLHED-affected infants to serious a potentially life-threatening hyperthermia and pneumonia.MedDRA version: 18.0Level: LLTClassification code 10072592Term: Hypohidrotic ectodermal dysplasiaSystem Organ Class: 100000004850
EUCTR2013-004565-14-FREdimer Pharmaceuticals, Inc.10
撤回
不适用
A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHEDXLHED
NCT03912792Dermelix Biotherapeutics, LLC.
已完成
不适用
Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia (ECP-012)X-linked Hypohidrotic Ectodermal DysplasiaHypohidrotic Ectodermal Dysplasia
NCT01629927Edimer Pharmaceuticals30
已完成
不适用
Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal DysplasiaX-linked Hypohidrotic Ectodermal Dysplasia
NCT01308333University Hospital Erlangen38
已完成
不适用
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction SurveyHypohidrotic Ectodermal DysplasiaX-Linked Hypohidrotic Ectodermal Dysplasia
NCT01398813Edimer Pharmaceuticals500