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

ConditionGuillain-Barre Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • intravenous immunoglobulin

    Drug

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

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Immunoadsorption groupExperimental treatment 1 intervention
Group B: intravenous immunoglobulin groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
4 weeks after starting treatment vs. baseline (before starting treatment)

Secondary outcomes

1

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.

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

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.

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.
3

Ventilator application time

For patients with ventilator-assisted ventilation, the length of time from the beginning of treatment to leaving the ventilator.

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.
4

Total time in ICU

The total time that patients in the protein A immunoadsorption or intravenous immunoglobulin group were admitted to the 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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: