Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT04035135
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome
* Onset of GBS-related weakness ≤14 days prior to infusion
* GBS-DS score of 3, 4, or 5
Exclusion Criteria:
* Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data
* Be at risk of suicide or self-harm
* Received previous treatment with plasma exchange for GBS
* Any diagnosis of a variant of GBS
* Have a history of anaphylaxis or severe systemic response to immunoglobulin
* Documented, clinically significant, pre-existing polyneuropathy from another cause
* Clinically significant intercurrent illness, medical condition, or medical history
* History of chronic use of steroid or immunosuppressant medication
* Active alcohol, drug, or substance abuse
* Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04035135
Study Brief:
Protocol Section:
NCT04035135