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

Exclusion Criteria

• •Subjects with pre-existing clinically significant lung disease not attributable to ALS
• •Subjects diagnosed with other neurodegenerative diseases or diseases associated with other motor neuron dysfunction
• •Participation in another investigational product study within one month prior to screening
• •Females who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/ gel/ film/ cream/ suppository, male sterilization, or true abstinence) throughout the study
• •Difficult or problematic peripheral vein access and inability to implant a central catheter which would make continuous Plasma exchange (PE) not feasible as per the visit protocol
• •Contraindication to undergo PE or subject has abnormal coagulation parameters at the discretion of the Outpatient Apheresis Unit team, including but not limited to:
• •1. Thrombocytopenia (platelets \<100,000/ microliter \[μL\])
• •2. Fibrinogen \<1.5 gram per liter (g/L)
• •3. International Normalized Ratio \>1.5
• •4. Beta-blocker treatment and bradycardia \<50 beats/min
• •5. Treatment with angiotensin-converting enzyme inhibitors which may increase the risk of allergic reactions, unless a preventive change in hypotensive treatment occurs prior to enrollment
• •History of anaphylaxis or severe systemic response to any plasma-derived albumin preparation, component of Albutein® 5%, or other blood product(s)
• •Subjects unable to interrupt treatment with acetylsalicylic acid, other oral antiplatelet, or anticoagulant
• •Renal dysfunction by elevated creatinine concentration \>2 milligram per deciliter (mg/dL)
• •Presence of heart disease that contraindicates PE treatment, including ischemic cardiopathy and congestive heart failure
• •Presence of prior behavioural disorders requiring pharmacological intervention with less than 3 months of stable treatment
• •Mentally challenged subject who cannot give independent informed consent
• •Any condition that would complicate compliance with the study protocol (i.e., illness with the expectation of less than one year survival, abuse of drugs or alcohol, etc.)