Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

NCT04303962 | Unknown

• 1 other identifier: MRCTA，ECFAH of FMU[2019]217
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain-barre Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Respiratory function

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with GBS after standard IVIg treatment in relation to slow clinical course or worse outcome

You may qualify if:

• Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
• Age ≥18;
• Patients with AIDP, AMAN and AMSAN;
• \. 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ning Wang, MD., PhD.: lead

Study Sites (1)

Department of Neurology,First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ning Wang, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu MD Jiitng, PhD

CONTACT

13559947905; zjtzjt11@yeah.net

Ying Fu, PhD

CONTACT

+8613920263688; fuying1995@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 11, 2020
• Study Start: April 27, 2020
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2025
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

CN (1)