The First Affiliated Hospital of Zhengzhou University
Phase
Not applicable
Started
2026-01-01
Last updated
2025-03-12
Condition(s) studied
Guillain-Barre Syndrome
Investigational drug(s) / intervention(s)
immunosorbent columnintravenous immunoglobulin
immunosorbent column: Immunoadsorption treatment regimen: the treatment is performed once every 1-3 days, at least 5 times, and the amount of regenerated plasma for each treatment is 1 to 3 times the plasma volume. The immunosorbent column adopts the protein A immunosorbent column.
intravenous immunoglobulin: Intravenous immunoglobulin treatment regimen: intravenous immunoglobulin therapy, 400mg/kg/d, once a day, for at least 5 consecutive days.
Study summary
Guillain-Barre syndrome is an immune-mediated acute inflammatory peripheral neuropathy. The currently effective treatment methods include intravenous immunoglobulin and plasma exchange. Immunoadsorption has been widely used to treat immune-related diseases. There are currently no prospective large-sample clinical trials of immunoadsorption therapy for Guillain-Barre syndrome. The neuro-intensive care unit of the First Affiliated Hospital of Zhengzhou University is preparing to carry out a prospective, multi-center, randomized parallel controlled clinical study on the efficacy and safety of protein A immunoadsorption and intravenous immunoglobulin (IVIG) in the treatment of Guillain-Barre syndrome. It is estimated that 204 patients with Guillain-Barre syndrome will be included. The patients will be randomly assigned to the immunoadsorption group and the IVIG group. The primary outcome measure: changes in Hughes scores (4 weeks after starting treatment vs. baseline (before starting treatment) ). This study aims to explore the efficacy and safety of protein A immunoadsorption and intravenous immunoglobulin in the treatment of Guillain-Barre syndrome.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Meet the diagnostic criteria of Guillain - Barre syndrome;
2. The onset is within 2 weeks;
3. Age is greater than or equal to 18 years old and less than or equal to 60 years old;
4. Hughes function classification is greater than or equal to 3;
5. The subject or his legal representative can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form.
Exclusion Criteria:
1. Those who are pregnant;
2. Three months before the screening period, receive immunoadsorption therapy or intravenous immunoglobulin therapy;
3. Those who have a history of allergies in the membrane of the plasma separator;
4. Those who must use angiotensin-converting enzyme inhibitor drugs within 1 week before being included in the trial and during treatment and cannot be stopped;
5. Severe active bleeding or diffuse intravascular coagulation, patients with systemic circulatory failure that are difficult to correct with drugs;
6. Severe cardiac insufficiency, that is, those who have reached NYHA IV according to the heart failure classification standards of the New York Heart Association (NYHA);
7. There are contraindications to intravenous immunoglobulin;
8. Those with other system autoimmune diseases;
9. Diagnosis of variant GBS: such as Miller-Fisher syndrome, GBS with cranial nerve damage, sensory GBS, pan-autonomous GBS. Patients with chronic inflammatory demyelinating polyperipheral neuropathy whose condition has been significantly alleviated when visiting a doctor;
10. Subjects who have participated in any other drug or medical device clinical trials within 1 month before entering the screening period; Note: Subjects who participated in observational studies (that is, the study does not require changes or other interventions) will not be excluded;
11. Patients who cannot obtain informed consent;
12. Those who cannot receive active and comprehensive treatment.
Primary outcome measure(s)
Changes in Hughes scores — 4 weeks after starting treatment vs. baseline (before starting treatment) Compared with the patient's Hughes score before treatment, the change of Hughes scores 4 weeks after the start of protein A immunoadsorption or intravenous immunoglobulin treatment.
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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