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Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303962
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University

Brief 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. 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.

Condition or disease
Guillain-barre Syndrome

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : January 21, 2024
Estimated Study Completion Date : January 21, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Respiratory function [ Time Frame: 6 months ]
    whether mechanical ventilation is required



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with GBS after standard IVIg treatment in relation to slow clinical course or worse outcome
Criteria

Inclusion Criteria:

  1. Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
  2. Age ≥18;
  3. 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;

Exclusion criteria:

  1. Age <18;
  2. Pregnant or nursing women;
  3. Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy;
  4. Combined with other types of immune system diseases;
  5. Accept drugs that affect the function of the immune system within 5 or 3 months;
  6. Concomitant neoplastic diseases.
  7. The patient or guardian refused to sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303962


Contacts
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Contact: Zhu MD Jiitng, PhD 13559947905 zjtzjt11@yeah.net
Contact: Ying Fu, PhD +8613920263688 fuying1995@163.com

Locations
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China, Fujian
Department of Neurology,First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Wang MD Ning, PhD    +86-0591-87982772    ningwang@fjmu.edu.cn   
Principal Investigator: Wang Ning, PhD         
Sponsors and Collaborators
Ning Wang, MD., PhD.
Investigators
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Principal Investigator: Ning Wang, MD First Affiliated Hospital of Fujian Medical University
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Responsible Party: Ning Wang, MD., PhD., Director, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04303962    
Other Study ID Numbers: MRCTA,ECFAH of FMU[2019]217
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases