Guillain-Barre SyndromeGBS-PRAISINGNCT05114941
Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome
A study testing immunosorbent column and intravenous immunoglobulin in people with Guillain-Barre Syndrome, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- immunosorbent column and intravenous immunoglobulin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wang Miao, Prof
Wang Miao, Prof
About this study
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
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.
Read the 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.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- immunosorbent column, intravenous immunoglobulin
- Keywords
- immunoadsorption, intravenous immunoglobulin
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunosorbent columnDevice
Also called Protein A Immunoadsorption
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 immunoglobulinDrug
Intravenous immunoglobulin treatment regimen: intravenous immunoglobulin therapy, 400mg/kg/d, once a day, for at least 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption group | Experimental | Protein A immunoadsorption therapy Receives: Device: immunosorbent column |
| intravenous immunoglobulin group | Active comparator | Treatment with intravenous immunoglobulin Receives: Drug: intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after starting treatment vs. baseline (before starting treatment)
Secondary outcomes (6)
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.
Measured: 2 weeks after starting treatment vs. baseline (before starting treatment)
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.
Measured: 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 with ventilator-assisted ventilation, the length of time from the beginning of treatment to leaving the ventilator.
Measured: 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
The total time that patients in the protein A immunoadsorption or intravenous immunoglobulin group were admitted to the ICU.
Measured: 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
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.
Measured: 2 weeks after starting treatment vs. baseline (before starting treatment)
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.
Measured: 4 weeks after starting treatment vs. baseline (before starting treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Miao, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Junfang Teng, Prof, Study director, The First Affiliated Hospital of Zhengzhou UniversityWang Miao, Prof, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114941
- Sponsor's protocol ID
- 2021-KY-0709
- Acronym
- GBS-PRAISING
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the clinical trial is completed, the individual participant data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05114941
- Acronym / sponsor ID
- GBS-PRAISING / 2021-KY-0709
- Conditions
- Guillain-Barre Syndrome
- Keywords
- immunoadsorption, intravenous immunoglobulin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption group | Experimental | Device: immunosorbent columnProtein A immunoadsorption therapy |
| intravenous immunoglobulin group | Active comparator | Drug: intravenous immunoglobulinTreatment with intravenous immunoglobulin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunosorbent columnAlso: Protein A ImmunoadsorptionImmunoadsorption 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. | Device | Immunoadsorption group |
| intravenous immunoglobulinIntravenous immunoglobulin treatment regimen: intravenous immunoglobulin therapy, 400mg/kg/d, once a day, for at least 5 consecutive days. | Drug | intravenous immunoglobulin group |
Primary outcome
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.
6 secondary outcomes
Changes in Hughes scores
Time frame: 2 weeks after starting treatment vs. baseline (before starting treatment)
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.
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.
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.
Changes of total lymphocyte count, interleukin-6, interleukin-8, cerebrospinal fluid protein
Time frame: 2 weeks after starting treatment vs. baseline (before starting treatment)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Yes. After the clinical trial is completed, the individual participant data will be shared with other researchers.
Related trials for Guillain-Barre Syndrome
Recruiting
High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Critical Illness Myopathy, Guillain Barré Syndrome
Not yet recruitingPhase 2
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
Guillain-Barré Syndrome (GBS)
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Not yet recruitingObservational study
Peripheral Nerve Ultrasound in Children With Guillain-Barré Syndrome
Guillain-Barre Syndrome
RecruitingObservational study
Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome
Guillain Barre Syndrome, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junfang Teng, Prof study director
The First Affiliated Hospital of Zhengzhou University
Wang Miao, Prof principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunosorbent column and intravenous immunoglobulin in people with Guillain-Barre Syndrome, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Miao, Prof (0086-13592567185, miaowang7211@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hughes scores (time frame: 4 weeks after starting treatment vs. baseline (before starting treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.