Guillain-barre SyndromeNCT04303962
Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome
An observational study of Guillain-barre Syndrome, run by Ning Wang, MD., PhD. at 1 site in China.
Trial summary
Guillain-barre syndrome (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guillain-barre Syndrome
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2020to 21 Jan 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with GBS after standard IVIg treatment in relation to slow clinical course or worse outcome
Who may be able to join
- Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
- Age ≥18;
- Patients with AIDP, AMAN and AMSAN;
- 5. IVIG was treated within 2 weeks of onset; 6. GBS disability scale>2; 6. Cooperate with patients who were followed up for 180 days and sign the informed consent;
Who cannot join
- Age <18;
- Pregnant or nursing women;
- Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy;
- Combined with other types of immune system diseases;
- Accept drugs that affect the function of the immune system within 5 or 3 months;
- Concomitant neoplastic diseases.
- The patient or guardian refused to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology,First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Wang MD Ning, PhD, +86-0591-87982772, ningwang@fjmu.edu.cn
Wang Ning, PhD
About this study
Official title: An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome
Guillain-barre syndrome (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. The establishment of a cohort study on the therapeutic effect of gamma globulin in Guillain-barre Syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.
- Conditions
- Guillain-barre Syndrome
- Medical subject headings
- Guillain-Barre Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
GBS disability score
GBS disability scale ( Guillain-Barré syndrome disability scale) was defined as follows: 0: healthy state; 1: minor symptoms and capable of running; 2: able to walk 5 meters or more without assistance but unable to run; 3: able to walk 5 meters across an open space with help; 4: bedridden or chair-bound; 5: requiring assisted ventilation for at least part of the day; 6: dead
Measured: 6 months
Secondary outcomes (1)
Respiratory function
whether mechanical ventilation is required
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start27 Apr 2020
- Primary completion21 Jan 2024 (estimated)
- Study completion21 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Wang, MD., PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
- Investigators
- Ning Wang, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303962
- Sponsor's protocol ID
- MRCTA，ECFAH of FMU[2019]217
- Status last verified
- Jan 2022
- First submitted
- 28 Feb 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome
- ClinicalTrials.gov ID
- NCT04303962
- Acronym / sponsor ID
- MRCTA，ECFAH of FMU[2019]217
- Conditions
- Guillain-barre Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ning Wang, MD., PhD.University, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 21 Jan 2024 (estimated)
- Study completion
- 21 Jan 2025 (estimated)
- First posted
- 11 Mar 2020 (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 (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. The establishment of a cohort study on the therapeutic effect of gamma globulin in Guillain-barre Syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GBS after standard IVIg treatment in relation to slow clinical course or worse outcome
Key inclusion criteria (4 listed)
- Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
- Age ≥18;
- Patients with AIDP, AMAN and AMSAN;
- 5. IVIG was treated within 2 weeks of onset; 6. GBS disability scale>2; 6. Cooperate with patients who were followed up for 180 days and sign the informed consent;
Key exclusion criteria (7 listed)
- Age <18;
- Pregnant or nursing women;
- Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy;
- Combined with other types of immune system diseases;
- Accept drugs that affect the function of the immune system within 5 or 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GBS disability score
Time frame: 6 months
GBS disability scale ( Guillain-Barré syndrome disability scale) was defined as follows: 0: healthy state; 1: minor symptoms and capable of running; 2: able to walk 5 meters or more without assistance but unable to run; 3: able to walk 5 meters across an open space with help; 4: bedridden or chair-bound; 5: requiring assisted ventilation for at least part of the day; 6: dead
1 secondary outcome
Respiratory function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
Ning Wang, MD principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain-barre Syndrome, run by Ning Wang, MD., PhD. 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 4 inclusion and 7 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 19 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu MD Jiitng, PhD (13559947905, zjtzjt11@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GBS disability score (time frame: 6 months). 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 19 Jan 2022.