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

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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).

Key facts

Study ID

NCT02872142

Run by

Grifols Therapeutics LLC

People needed

12

Starts

2016-08-29

Expected to finish

2019-08-15

Last updated by the study team

2021-05-05

Who can join

Age: 19 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Subjects over 18 years of age and less than 70 years old
• Subjects with a possible, probable-lab supported, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis (ALS), according to the revised El Escorial criteria
• Subjects having experienced their first ALS symptoms within 18 months prior to recruitment/consent
• Forced Vital Capacity > 70%
• Subjects must be medically suitable for study participation and willing to comply with all planned aspects of the protocol, including blood sampling, at the time of inclusion in the study.

You may not qualify if…

• 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:
• Thrombocytopenia (platelets <100,000/ microliter [μL])
• Fibrinogen <1.5 gram per liter (g/L)
• International Normalized Ratio >1.5
• Beta-blocker treatment and bradycardia <50 beats/min
• 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.)

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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