Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guil… (NCT05114941) | Clinical Trial Compass
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Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome
China204 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Meet the diagnostic criteria of Guillain - Barre syndrome;
✓. The onset is within 2 weeks;
✓. Age is greater than or equal to 18 years old and less than or equal to 60 years old;
✓. Hughes function classification is greater than or equal to 3;
✓. 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
✕. Those who are pregnant;
✕. Three months before the screening period, receive immunoadsorption therapy or intravenous immunoglobulin therapy;
✕. Those who have a history of allergies in the membrane of the plasma separator;
✕. 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;
What they're measuring
1
Changes in Hughes scores
Timeframe: 4 weeks after starting treatment vs. baseline (before starting treatment)
Trial details
NCT IDNCT05114941
SponsorThe First Affiliated Hospital of Zhengzhou University
✕. Severe active bleeding or diffuse intravascular coagulation, patients with systemic circulatory failure that are difficult to correct with drugs;
✕. 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);
✕. There are contraindications to intravenous immunoglobulin;