Performance Evaluation of plasma fraction filter FRACTIOsmart L in comparison to the Cascadeflo EC 50 in regular lipoprotein apheresis setting

Kaneka Pharma Europe NV0 个研究点目标入组 6 人开始时间: 2021年5月28日最近更新: 2024年8月19日

适应症

试验速览

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•Min. 18 years, max. 70 years (male and female)
•- Consent of patient
•- Indication for LDL-apheresis according to the directive of the Bundesausschusses zu Untersuchungs- und Behandlungsmethoden der vertragsärztlichen Versorgung (Richtlinie Methoden vertragsärztliche Versorgung), Anlage I, 1 Ambulante Durchführung der Apheresen als extrakorporales Hämotherapieverfahren (BAnz AT 14.04.2020 B5)
•- Body weight > 60 kg, < 100 kg
•- Hkt > 40, < 50
•- Min. since 3 month weekly LDL apheresis treatment
•- Effective contraception for women of childbearing age

•- Patients unable to consent according MPG § 20 clause 2 sentence 1 nr. 1
•- Pregnant and breastfeeding women’s and those that will become pregnant
•- Participation at another study during the last month
•- Patients with known or expected allergic reaction against the study product and other products
•- Scheduled absence during the study duration for the patient of the 8-weeks (for example schedule hospitalization, holidays, …)
•- Known tumor disease
•- Patients with antihypertensive therapy via ACE inhibitor, because of higher risk for Bradykinin induced anaphylactic shock

发起方

Kaneka Pharma Europe NV