Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

NCT ID: NCT04303962

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-27

Study Completion Date

2025-01-21

Brief Summary

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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

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Conditions

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Guillain-barre Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ning Wang, MD., PhD.

OTHER

Sponsor Role lead

Responsible Party

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Ning Wang, MD., PhD.

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ning Wang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

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Department of Neurology,First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhu MD Jiitng, PhD

Role: CONTACT

13559947905

Ying Fu, PhD

Role: CONTACT

+8613920263688

Facility Contacts

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Wang MD Ning, PhD

Role: primary

+86-0591-87982772

Other Identifiers

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MRCTA,ECFAH of FMU[2019]217

Identifier Type: -

Identifier Source: org_study_id

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