Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Comparison of the Effects of 2 Therapeutic Plasmapheresis Techniques: Single Plasma Exchange and Double Filtration Plasmapheresis (DFPP) on Peripheral Lymphocyte Phenotypes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). A Monocentric Prospective Study With a Single-Case Experimental Design

ID
Name
NIMAO/2020-01/OM001
Description
CIDP, a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without antibodies but with modified cell profiles have been described. Treatments include corticotherapy, IVIg and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques - single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques.
Trial arms
Trial start
2021-02-01
Estimated PCD
2022-02-03
Trial end
2022-02-03
Status
Completed
Phase
Early phase I
Treatment
Blood sampling
Blood sampling before and after each type of cycle, Single Plasma Exchange or Double Filtration Plasmapheresis
Arms:
Group A, Group B
Size
8
Primary endpoint
Cycle 1, Group A : TH1 cells BEFORE single plasma exchange
Day 0, Time 0
Cycle 1, Group A : TH1 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 1, Group A : TH1 cells 7-10 days AFTER single plasma exchange
Day 7 -10
Cycle 1, Group A : TH17 cells BEFORE first single plasma exchange
Day 0, Time 0
Cycle 1, Group A : TH17 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 1, Group A : TH17 cells 7 - 10 days AFTER single plasma exchange
Day 7 - 10
Cycle 1, Group A : T-reg cells BEFORE first single plasma exchange
Day 0, Hour 0
Cycle 1, Group A : T-reg cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 1, Group A : T-reg cells 7 - 10 days AFTER single plasma exchange
Day 7 - 10
Cycle 1, Group B : TH1 cells BEFORE first double filtration plasmapheresis
Day 0, Hour 0
Cycle 1, Group B : TH1 cells AFTER the first double filtration plasmapheresis
Day 0, Hour 3
Cycle 1, Group B : TH1 cells 7-10 days AFTER the first double filtration plasmapheresis
Day 7 - 10
Cycle 1, Group B : TH17 cells BEFORE the first double filtration plasmapheresis
Day0, Hour 0
Cycle 1, Group B : TH17 cells AFTER the first double filtration plasmapheresis
Day 0, Hour 3
Cycle 1, Group B : T17 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 1, Group B : T-reg cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 1, Group B : T-reg cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 1, Group B : T-reg cells 7-10 days AFTER double filtration plasmapheresis
Day 7 - 10
Cycle 2, Group A: TH1 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 2, Group A: TH1 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 2, Group A: TH1 cells 7-10 days AFTER double filtration plasmapheresis
Day 7 - 10
Cycle 2, Group A: TH17 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 2, Group A: TH17 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 2, Group A: TH17 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 2, Group A: T-reg cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 2, Group A: T-reg cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 2, Group A: T-reg cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 2, Group B: TH1 cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 2, Group B: TH1 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 2, Group B: TH1 cells 7-10 days AFTER single plasma exchange
Day 7-10
Cycle 2, Group B: T17 cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 2, Group B: TH17 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 2, Group B: TH17 cells 7-10 days AFTER single plasma exchange
Day 7-10
Cycle 2, Group B: T-reg cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 2, Group B: T-reg cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 2, Group B: T-reg cells 7-10 days AFTER single plasma exchange
Day 7-10
Cycle 3, Group A: TH1 cells BEFORE single plasma exchange
Day 1, Hour 1
Cycle 3, Group A: TH1 cells AFTER single plasma exchange
Day 1, Hour 3
Cycle 3, Group A: T1 cells 7-10 days AFTER single plasma exchange
Day 7 - 10
Cycle 3, Group A: TH17 cells BEFORE single plasma exchange
Day 1, Hour 1
Cycle 3, Group A: TH17 cells AFTER single plasma exchange
Day 1, Hour 3
Cycle 3, Group A: TH17 cells 7-10 days AFTER single plasma exchange
Day 7 - 10
Cycle 3, Group A: T-reg cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 3, Group A: T-reg cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 3, Group A: T-reg cells 7-10 days AFTER single plasma exchange
Day 7-10
Cycle 3, Group B: TH1 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 3, Group B: TH1 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 3, Group B: TH1 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 3, Group B: TH17 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 3, Group B: TH17 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 3, Group B: TH17 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 3, Group B: T-reg cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 3, Group B: T-reg cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 3, Group B: T-reg cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 4, Group A: T1 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 4, Group A: T1 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 4, Group A: TH1 cells 7-10 days AFTER double filtration plasmapheresis
Day 7 - 10
Cycle 4, Group A: TH17 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 4, Group A: TH17 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 4, Group A: TH17 cells 7-10 days AFTER double filtration plasmapheresis
Day 7 - 10
Cycle 4, Group A: T-reg cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 4, Group A: T-reg cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 4, Group A: T-reg cells 7-10 days AFTER double filtration plasmapheresis
Day 7 - 10
Cycle 4, Group B : TH1 cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 4, Group B : TH1 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 4, Group B : TH1 cells 7-10 days AFTER single plasma exchange
Day 7 -10
Cycle 4, Group B : TH17 cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 4, Group B : TH17 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 4, Group B : T17 cells 7-10 days AFTER single plasma exchange
Day 7 -10
Cycle 4, Group B : T-reg cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 4, Group B : T-reg cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 4, Group B : T-reg cells 7-10 days AFTER single plasma exchange
Day 7 - 10
Cycle 5, Group A : TH1 cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 5, Group A : TH1 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 5, Group A : TH1 cells 7-10 days AFTER single plasma exchange
Day 7 - 10
Cycle 5, Group A : TH17 cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 5, Group A : TH17 cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 5, Group A : TH17 cells 7-10 days AFTER single plasma exchange
Day 7 - 10
Cycle 5, Group A : T-reg cells BEFORE single plasma exchange
Day 0, Hour 0
Cycle 5, Group A : T-reg cells AFTER single plasma exchange
Day 0, Hour 3
Cycle 5, Group A : T-reg cells 7-10 days AFTER single plasma exchange
Day 7 - 10
Cycle 5, Group B : TH1 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 5, Group B : TH1 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 5, Group B : TH1 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 5, Group B : TH17 cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 5, Group B : TH17 cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 5, Group B : TH17 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 5, Group B : T-reg cells BEFORE double filtration plasmapheresis
Day 0, Hour 0
Cycle 5, Group B : T-reg cells AFTER double filtration plasmapheresis
Day 0, Hour 3
Cycle 5, Group B : T-reg cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 6, Group A : TH1 cells BEFORE double filtration plasmapheresis
Day 0 Hour 0
Cycle 6, Group A : TH1 cells AFTER double filtration plasmapheresis
Day 0 Hour 3
Cycle 6, Group A : TH1 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 6, Group A : TH17 cells BEFORE double filtration plasmapheresis
Day 0 Hour 0
Cycle 6, Group A : TH17 cells AFTER double filtration plasmapheresis
Day 0 Hour 3
Cycle 6, Group A : TH17 cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 6, Group A : T-reg cells BEFORE double filtration plasmapheresis
Day 0 Hour 0
Cycle 6, Group A : T-reg cells AFTER double filtration plasmapheresis
Day 0 Hour 3
Cycle 6, Group A : T-reg cells 7-10 days AFTER double filtration plasmapheresis
Day 7-10
Cycle 6, Group B : TH1 cells BEFORE single plasma exchange
Day 0 Hour 0
Cycle 6, Group B : TH1 cells AFTER single plasma exchange
Day 0 Hour 3
Cycle 6, Group B : TH1 cells 7-10 days AFTER single plasma exchange
Day 7-10
Cycle 6, Group B : TH17 cells BEFORE single plasma exchange
Day 0 Hour 0
Cycle 6, Group B : TH17 cells AFTER single plasma exchange
Day 0 Hour 3
Cycle 6, Group B : TH17 cells 7-10 days AFTER single plasma exchange
Day 7-10
Cycle 6, Group B : T-reg cells BEFORE single plasma exchange
Day 0 Hour 0
Cycle 6, Group B : T-reg cells AFTER single plasma exchange
Day 0 Hour 3
Cycle 6, Group B : T-reg cells 7-10 days AFTER single plasma exchange
Day 7-10
Eligibility criteria
Inclusion Criteria: * Patients with confirmed Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) without pathogenic antibodies and stable under therapeutic plasmapheresis with one session every 2-3 weeks for at least two months. * Patients who have given free written informed consent. * Patients who have signed the consent form. * Patients affiliated to or beneficiaries of a health insurance scheme. * Adult patients (≥18 ans). * Healthy subjects of the same age and sex Exclusion Criteria: * Patients Under the age of 18. * Patients under immunosuppressive treatment for less than 3 months. * Patients participating in Category 1 research involving human subjects. * Patients in an exclusion period determined by another study. * Patients under legal protection, guardianship or curatorship. * Patients unable to express consent. * Patients for whom it is impossible to give informed information. * Pregnant, parturient or breastfeeding patients. * Healthy subject with chronic pathology or drug treatment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Proof-of-concept, monocentric, prospective, Single-Case Experimental Design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Randomisation to one of two treatments before alternation.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 product

2 indications

Organization
Centre Hospitalier Universitaire de Nīmes
Product
Blood sampling
Indication
Polyradiculoneuropathy
Indication
Chronic Inflammatory Demyelinating