Last updated on August 2019

Efficacy and Safety of Plasma Exchange With Albutein 5% in Patients With Amyotrophic Lateral Sclerosis

Brief description of study

This is a pilot, phase 2, prospective, open-label, single-arm study to evaluate disease progression, forced vital capacity, and the safety and tolerability of plasma exchange (PE) using Albutein 5% in subjects with amyotrophic lateral sclerosis (ALS).

Detailed Study Description

This is a phase 2, prospective, open-label, single-arm pilot study to evaluate the efficacy and safety of PE with Albutein 5% in subjects with ALS. The planned enrollment is 10 subjects who have a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria. Enrolled subjects will be treated with PE using Albutein 5% as a replacement solution during an Intensive Treatment Phase (2 PEs per week over 3 weeks) followed by a Maintenance Treatment Phase (weekly PE for 21 weeks) for a total treatment duration of 6 months. A 6-month follow up will begin after the last PE.

Clinical Study Identifier: NCT02872142

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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