临床试验/NCT02044692

NCT02044692Unknown不适用

The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Green Cross Corporation1 个研究点分布在 1 个国家目标入组 34 人开始时间: 2014年1月最近更新: 2014年6月20日

适应症

试验速览

阶段: 不适用
发起方: Green Cross Corporation
入组人数: 34
试验地点: 1
主要终点: Incidence of adverse event and adverse drug reaction.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients

研究设计

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

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
•Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
•Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.

排除标准

•Patients who have participated in any other blind clinical trials.
•Patient who cannot be tracked about safety.
•Patients who are judged disqualified to participate clinical trials by investigator for other causes.

结局指标

主要结局

Incidence of adverse event and adverse drug reaction.

时间窗: Once a week up to 5years

次要结局

Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status.(Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years))

研究者

发起方

Green Cross Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

3 期

Safety and Efficacy of HunteraseHunter Syndrome

NCT01645189Green Cross Corporation6

Unknown

早期 1 期

The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette SyndromeTourette Syndrome

NCT02253498Beijing Pins Medical Co., Ltd20

进行中（未招募）

3 期

Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia VeraPolycythemia Vera

NCT06033586Protagonist Therapeutics, Inc.46

Unknown

早期 1 期

The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive DisorderObsessive-Compulsive Disorder

NCT02253472Beijing Pins Medical Co., Ltd30

已完成

不适用

Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis SuppurativaHidradenitis Suppurativa (HS)

NCT03894956AbbVie46