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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04303962
Other study ID # MRCTA,ECFAH of FMU[2019]217
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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