Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome — GBS-PRAISING  

Guillain-Barre Syndrome Clinical Trial

Official title: A Prospective, Multi-center, Randomized Parallel Controlled Clinical Study on the Efficacy and Safety of Protein A Immunoadsorption and Intravenous Immunoglobulin in the Treatment of Guillain-Barre Syndrome

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Guillain-Barre syndrome (GBS) is an immune-mediated acute inflammatory peripheral neuropathy. The currently proven effective treatment methods include intravenous immunoglobulin and plasma exchange. In the clinical treatment process, the plasma source is often stressed, forcing the treatment to be terminated. Intravenous immunoglobulin therapy may cause allergies. Based on the above reasons, immunosorbent technology came into being.

Immunoadsorption technology is widely used in clinical treatment of immune-related diseases. Protein A can recognize and bind to the Fc segment of human antibodies. The protein A immunosorbent column uses recombinant staphylococcal protein A as its ligand. The protein can specifically recognize and bind to the Fc segment of human antibodies, so it can adsorb human antibodies, mainly immunoglobulin G, and can adsorb immunoglobulin M and immunoglobulin A at the same time. The binding of protein A and antibody is reversible.

Immunoadsorption therapy has obvious advantages: The patient's own plasma is transfused without replacement fluid; It can prevent infection Diseases such as viral hepatitis, AIDS, etc.; The adsorption is selective or specific, and normal plasma components including coagulation factors, etc., only slightly decrease; Does not affect the simultaneous drug treatment; The protein A immunosorbent column can be reused; The treatment effect is better, and the amount of plasma purified by a single immunoadsorption is 1.5 to 3 times that of plasma exchange.

The First Affiliated Hospital of Zhengzhou University is preparing to carry out a prospective, multi-center, randomized parallel controlled clinical study on the effectiveness and safety of protein A immunoadsorption and intravenous immunoglobulin in the treatment of Guillain-Barre syndrome. The control group received intravenous immunoglobulin injections using the standard treatment recommended by the Guilan-Barre Syndrome Guidelines. Compare the effectiveness and safety of the two treatment regimens in the treatment of Guillain-Barre syndrome, and explore a more effective and safe treatment regimen for the treatment of Guillain-Barre syndrome. ;

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Syndrome

• NCT number: NCT05114941
• Study type: Interventional
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Wang Miao, Prof
• Phone: 0086-13592567185
• Email: miaowang7211@126.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: December 31, 2024