An open-label, multicenter, Post-Marketing Requirement study to investigate the safety and tolerability of octaplas™ in the management of pediatric patients who require therapeutic plasma exchange.

Octapharma0 个研究点目标入组 41 人开始时间: 2020年2月12日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•1. Patients in whom therapeutic plasma exchange is required.
•2. Patient is male or female ? 2 years to ? 20 years of age.
•3. Patient or patient’s legal representative(s)/guardian(s) has /have given voluntarily written and signed informed consent before any study-related procedure is to be performed. If children are old enough (age usually deemed by each institution) to understand the risks and benefits of the study, they should also be informed and provide their written assent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Patient with known homozygous congenital deficiency of Protein S.
•2. Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
•3. Patient has an already known IgA deficiency with documented antibodies against IgA.
•4. Patient is currently participating in another interventional clinical study or has participated during the past 1 month prior to study inclusion. This is not applicable to non-interventional trials and does not exclude patients who have been exposed to Investigational Medicinal Product with a washout of at least 30 days from enrollment in LAS-213. Concurrent participation in a device study will be considered on a case by case basis.
•5. Patient is pregnant.
•6. Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the first infusion episode or planned used of these medications while on study.

发起方