Guillain-Barre SyndromePhase 4NCT06041451
Early and Late Prognosis in Patients With Guillain-Barre Syndrome
A Phase 4 study testing Intravenous Immunoglobulins, Human and Methylprednisolone 500 MG Injection in people with Guillain-Barre Syndrome, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Intravenous Immunoglobulins, Human and Methylprednisolone 500 MG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2013to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.
Who cannot join
- nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
Trial locations and contacts
1 site in 1 country.
Binbin Deng contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Binbin Deng, Doctor, +8613695720610, dbinbin@aliyun.com
About this study
The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.
Read the detailed description
This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- Intravenous Immunoglobulins, Human, Methylprednisolone 500 MG Injection
- Keywords
- Guillain-barre syndrome, prognosis
- 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.
Intravenous Immunoglobulins, HumanDrug
patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
Methylprednisolone 500 MG InjectionDrug
patients were treated with methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| immunoglobulin group | Experimental | This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days Receives: Drug: Intravenous Immunoglobulins, Human |
| methylprednisolone group | Experimental | This group of patients was treated with methylprednisolone 500 MG Injection Receives: Drug: Methylprednisolone 500 MG Injection |
| control group | No intervention | This group of patients was treated without immunoglobulin or hormone |
| mixed group | Experimental | This group of patients was treated both with intravenous immunoglobulin and methylprednisolone. Receives: Drug: Intravenous Immunoglobulins, Human; Drug: Methylprednisolone 500 MG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of Guillain-barre syndrome
The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.
Measured: baseline, at 1 week, at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start2 Jan 2013
- Primary completion1 Dec 2022
- Study completion31 Jan 2025 (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 First Affiliated Hospital of Wenzhou Medical 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041451
- Sponsor's protocol ID
- Dengbinbin
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Prognosis in Patients With Guillain-Barre Syndrome
- ClinicalTrials.gov ID
- NCT06041451
- Acronym / sponsor ID
- Dengbinbin
- Conditions
- Guillain-Barre Syndrome
- Keywords
- Guillain-barre syndrome, prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Jan 2013 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 18 Sep 2023 (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.
The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.
Detailed description
This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| immunoglobulin group | Experimental | Drug: Intravenous Immunoglobulins, HumanThis group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days |
| methylprednisolone group | Experimental | Drug: Methylprednisolone 500 MG InjectionThis group of patients was treated with methylprednisolone 500 MG Injection |
| control group | No intervention | –This group of patients was treated without immunoglobulin or hormone |
| mixed group | Experimental | Drug: Intravenous Immunoglobulins, Human, Drug: Methylprednisolone 500 MG InjectionThis group of patients was treated both with intravenous immunoglobulin and methylprednisolone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.
Key exclusion criteria (1 listed)
- nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
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 |
|---|---|---|
| Intravenous Immunoglobulins, Humanpatients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days | Drug | immunoglobulin group, mixed group |
| Methylprednisolone 500 MG Injectionpatients were treated with methylprednisolone | Drug | methylprednisolone group, mixed group |
Primary outcome
the severity of Guillain-barre syndrome
Time frame: baseline, at 1 week, at 26 weeks
The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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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. This study is not recruiting at the moment.
Binbin Deng contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Immunoglobulins, Human and Methylprednisolone 500 MG Injection in people with Guillain-Barre Syndrome, run by First Affiliated Hospital of Wenzhou Medical 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binbin Deng (dbinbin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the severity of Guillain-barre syndrome (time frame: baseline, at 1 week, at 26 weeks). 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 18 Sep 2023.