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

NCT05114941 | Not Yet Recruiting

• 1 other identifier: 2021-KY-0709
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain-Barre Syndrome

Keywords

immunoadsorption; intravenous immunoglobulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in Hughes scores

  2 weeks after starting treatment vs. baseline (before starting treatment)

• Reached Hughes Grade 2

  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.

• Ventilator application time

  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.

• Total time in 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.

• Changes of total lymphocyte count, interleukin-6, interleukin-8, cerebrospinal fluid protein

  2 weeks after starting treatment vs. baseline (before starting treatment)

Study Arms (2)

Immunoadsorption group

EXPERIMENTAL

Protein A immunoadsorption therapy

Device: immunosorbent column

intravenous immunoglobulin group

ACTIVE COMPARATOR

Treatment with intravenous immunoglobulin

Drug: intravenous immunoglobulin

Interventions

immunosorbent column DEVICE

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.

Also known as: Protein A Immunoadsorption

Immunoadsorption group

intravenous immunoglobulin DRUG

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

intravenous immunoglobulin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Those with other system autoimmune diseases;
• 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;
• 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;
• Patients who cannot obtain informed consent;
• Those who cannot receive active and comprehensive treatment.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Junfang Teng, Prof

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

• Wang Miao, Prof

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Miao, Prof

CONTACT

0086-13592567185; miaowang7211@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 10, 2021
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available after five years, permanent.
• Access Criteria: No.

Locations

CN (1)