跳至主要内容
临床试验/EUCTR2014-003877-40-DE
EUCTR2014-003877-40-DE进行中(未招募)1 期

A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients with Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Clinical Study with Patisiran

Alnylam Pharmaceuticals, Inc.0 个研究点目标入组 228 人开始时间: 2015年10月5日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
228

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. Have completed a patisiran study
  • 2. Adequate liver function and renal function
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 114
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 114

排除标准

  • 1. Pregnant or nursing
  • 2. Have uncontrolled clinically significant cardiac arrhythmia or unstable angina

研究者

相似试验

进行中(未招募)
1 期
Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301
EUCTR2012-003176-39-IEBiogen Idec Research Limited1,600
已完成
不适用
ALN-TTR02-006Hereditary transthyretin-mediated amyloidosis(hATTR amyloidosis)
JPRN-jRCT2080224174Alnylam Pharmaceuticals, Inc. / Medpace Japan KK211
进行中(未招募)
1 期
Study to Evaluate the Long-term Safety and Efficacy of Patisiran (ALN-TTR02) in Patients with Familial Amyloidotic Polyneuropathy (FAP)Transthyretin mediated amyloidosis (ATTR)MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10019889Term: Hereditary neuropathic amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
EUCTR2014-003877-40-CYAlnylam Pharmaceuticals, Inc.228
进行中(未招募)
1 期
Study to Evaluate the Long-term Safety and Efficacy of Patisiran (ALN-TTR02) in Patients with Familial Amyloidotic Polyneuropathy (FAP)Transthyretin mediated amyloidosis (ATTR)MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10019889Term: Hereditary neuropathic amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
EUCTR2014-003877-40-ITALNYLAM PHARMACEUTICALS, INC.228
进行中(未招募)
1 期
Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301Relapsing-remitting Multiple SclerosisMedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
EUCTR2012-003176-39-CZBiogen Idec Research Limited1,600