At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study to Evaluate the Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral Sclerosis
In Brief
A Phase 2 clinical trial evaluating Albutein 5% and Plasma Exchange for Amyotrophic Lateral Sclerosis. Completed, enrolled 12 participants across 1 site.
Detailed Summary
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 participants with amyotrophic lateral sclerosis (ALS).
Study Details
Timeline
Interventions
Albutein is manufactured from human plasma. The dose of Albutein 5% for replacement following plasma removal will be calculated based on gender, weight, and the hematocrit of the participant.
Plasma Exchange will be performed using albutein 5% as the replacement solution.