Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

Guillain-barre Syndrome Clinical Trial

Official title:

An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303962
• Other study ID #: MRCTA,ECFAH of FMU[2019]217
• Status: Recruiting
• Start date: April 27, 2020
• Est. completion date: January 21, 2025

Study information

• Verified date: January 2022
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Zhu MD Jiitng, PhD
• Phone: 13559947905
• Email: zjtzjt11[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 21, 2025
• Est. primary completion date: January 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Guillain-barre Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Department of Neurology,First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Ning Wang, MD., PhD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Respiratory function	whether mechanical ventilation is required	6 months