Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis

NCT ID: NCT02479802

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-06-30

Brief Summary

Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5% albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic Lateral Sclerosis (ALS).

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albumin

Plasma exchange with Albumin

Group Type: EXPERIMENTAL

Albumin

Intervention Type: BIOLOGICAL

27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:

• three weeks of intensive treatment with two plasma exchanges per week
• twenty-one weeks of maintenance treatment with one weekly plasma exchange

Interventions

Albumin

27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:

• three weeks of intensive treatment with two plasma exchanges per week
• twenty-one weeks of maintenance treatment with one weekly plasma exchange

Intervention Type: BIOLOGICAL

Other Intervention Names

Human Albumin 5%; Albutein 5%

Eligibility Criteria

Inclusion Criteria

• Signed written-informed consent.
• Subjects over 18 years of age, and less than 70 years old.
• Subjects with a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria.
• Subjects having experienced their first ALS symptoms within 18 months before recruitment/consent.
• FVC > 70%
• Subjects must be medically suitable for study participation and of complying with all planned aspects of the protocol including blood sampling at the time of inclusion in the study.

Exclusion Criteria

• Subjects with a clinically significant preexisting lung disease not attributable to ALS.
• Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
• Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
• Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
• Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
• Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team
• A history of frequent adverse reactions (serious or otherwise) to blood products.
• Hypersensitivity to albumin or allergies to any of the components of Albutein.
• Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants
• Plasma creatinine > 2mg/dl.
• Present a history of heart disease including ischemic heart disease or congestive heart failure.
• Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
• Any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

References

Povedano M, Paipa A, Barcelo M, Woodward MK, Ortega S, Dominguez R, Aragones ME, Horrillo R, Costa M, Paez A. Plasma exchange with albumin replacement and disease progression in amyotrophic lateral sclerosis: a pilot study. Neurol Sci. 2022 May;43(5):3211-3221. doi: 10.1007/s10072-021-05723-z. Epub 2021 Nov 18.

Reference Type: DERIVED

PMID: 34791571 (View on PubMed)

Other Identifiers

IG1309

Identifier Type: -

Identifier Source: org_study_id