Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

Recruiting

• Conditions: Guillain-barre Syndrome

• Registration Number: NCT04303962
• Lead Sponsor: Ning Wang, MD., PhD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Study Start: 2020-04-27
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19
• Primary Completion: 2024-01-21
• Study Completion: 2025-01-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;

2. Age ≥18;

3. Patients with AIDP, AMAN and AMSAN;

4. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GBS disability score	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

Name	Time	Method
Respiratory function	6 months	whether mechanical ventilation is required

Trial Locations

Locations (1)

Department of Neurology,First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China