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

• ClinicalTrials.gov Identifier: NCT05114941
• Recruitment Status: Not yet recruiting
• First Posted: November 10, 2021
• Last Update Posted: March 16, 2022
• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Information provided by (Responsible Party): Wang Miao, The First Affiliated Hospital of Zhengzhou University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Guillain-Barre Syndrome	Device: immunosorbent column; Drug: intravenous immunoglobulin	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: September 1, 2022
• Estimated Primary Completion Date: December 1, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Immunoadsorption group; Protein A immunoadsorption therapy	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.; Other Name: Protein A Immunoadsorption
Active Comparator: intravenous immunoglobulin group; Treatment with intravenous immunoglobulin	Drug: intravenous immunoglobulin; Intravenous immunoglobulin treatment regimen: intravenous immunoglobulin therapy, 400mg/kg/d, once a day, for at least 5 consecutive days.

Outcome Measures

Primary Outcome Measures :

1. Changes in Hughes scores [ Time Frame: 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.

Secondary Outcome Measures :

1. Changes in Hughes scores [ Time Frame: 2 weeks after starting treatment vs. baseline (before starting treatment) ]
   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. Reached Hughes Grade 2 [ Time Frame: 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. ]
   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.
3. Ventilator application time [ Time Frame: 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. ]
   For patients with ventilator-assisted ventilation, the length of time from the beginning of treatment to leaving the ventilator.
4. Total time in ICU [ Time Frame: 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. ]
   The total time that patients in the protein A immunoadsorption or intravenous immunoglobulin group were admitted to the ICU.
5. Changes of total lymphocyte count, interleukin-6, interleukin-8, cerebrospinal fluid protein [ Time Frame: 2 weeks after starting treatment vs. baseline (before starting treatment) ]
   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.
6. Changes of Compound muscle action potential and motor nerve conduction velocity of bilateral tibial nerves [ Time Frame: 4 weeks after starting treatment vs. baseline (before starting treatment) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Wang Miao, Prof; 0086-13592567185; miaowang7211@126.com

Locations

China, Henan

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Contact: Wang Miao, Prof

Principal Investigator: Wang Miao, Prof

Sponsors and Collaborators

The First Affiliated Hospital of Zhengzhou University

Investigators

• Study Director: Junfang Teng, Prof; The First Affiliated Hospital of Zhengzhou University
• Principal Investigator: Wang Miao, Prof; The First Affiliated Hospital of Zhengzhou University

More Information

• Responsible Party: Wang Miao, professor, The First Affiliated Hospital of Zhengzhou University
• ClinicalTrials.gov Identifier: NCT05114941
• Other Study ID Numbers: 2021-KY-0709
• First Posted: November 10, 2021
• Last Update Posted: March 16, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After the clinical trial is completed, the individual participant data will be shared with other researchers.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Available after five years, permanent.
• Access Criteria: No.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wang Miao, The First Affiliated Hospital of Zhengzhou University:

immunoadsorption; intravenous immunoglobulin

Additional relevant MeSH terms:

Guillain-Barre Syndrome; Syndrome; Disease; Pathologic Processes; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Polyneuropathies; Autoimmune Diseases; Immune System Diseases; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin; Immunologic Factors; Physiological Effects of Drugs