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

Guillain-Barre Syndrome Clinical Trial

— GBS-PRAISING  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05114941
• Other study ID #: 2021-KY-0709
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Wang Miao, Prof
• Phone: 0086-13592567185
• Email: miaowang7211[@]126.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Syndrome

Intervention

Device:
• 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.

Drug:
• intravenous immunoglobulin
Intravenous immunoglobulin treatment regimen: intravenous immunoglobulin therapy, 400mg/kg/d, once a day, for at least 5 consecutive days.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hughes scores	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.	4 weeks after starting treatment vs. baseline (before starting treatment)
Secondary	Changes in Hughes scores	Compared with the patient's Hughes score before treatment, the change of Hughes scores 2 weeks after the start of protein A immunoadsorption or intravenous immunoglobulin treatment.	2 weeks after starting treatment vs. baseline (before starting treatment)
Secondary	Reached Hughes Grade 2	The time from the start of treatment to the patient's recovery to Hughes Grade 2. The time from the start of protein A immunoadsorption or intravenous immunoglobulin treatment to the time the patient recovers to be able to walk independently for a distance of more than 5 meters.	From date of first treatment until the date of patient's recovery to Hughes Grade 2 or end date of clinical trial, whichever came first, assessed up to 4 weeks.
Secondary	Ventilator application time	For patients with ventilator-assisted ventilation, the length of time from the beginning of treatment to leaving the ventilator.	For patients who require ventilator-assisted ventilation, from date of start use ventilator until participants leave the ventilator or end date of clinical trial, whichever came first, assessed up to 4 weeks.
Secondary	Total time in ICU	The total time that patients in the protein A immunoadsorption or intravenous immunoglobulin group were admitted to the ICU.	From the date the patient enters the ICU until the patient leaves the ICU or the clinical trial ends, whichever came first, assessed up to 4 weeks.
Secondary	Changes of total lymphocyte count, interleukin-6, interleukin-8, cerebrospinal fluid protein	Compared with the results before treatment, changes of total lymphocyte count, interleukin-6, interleukin-8, cerebrospinal fluid protein after 2 weeks of the start of the treatment.	2 weeks after starting treatment vs. baseline (before starting treatment)
Secondary	Changes of Compound muscle action potential and motor nerve conduction velocity of bilateral tibial nerves	Changes of Compound muscle action potential and motor nerve conduction velocity of bilateral tibial nerves before the treatment and 4 weeks after the start of the treatment in the protein A immunoadsorption or intravenous immunoglobulin group.	4 weeks after starting treatment vs. baseline (before starting treatment)