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Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis: | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

A Phase 2a, Prospective, Open-label, Single-arm, Single Center, Proof of Concept Study to Evaluate the Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis

NCT04175522•Green Cross Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, aged more than 12 years.(adolescent or adult)
•2. Subject who all three of the following diagnosis criteria for possible autoimmune encephalitis have been met.
•* Subacute onset (rapid progression of less than 3 months) of working memory deficits(short-term memory loss), altered mental status, or psychiatric symptoms.
•* At least one of the following:
•* New focal CNS findings
•* Seizure not explained by a previously known seizure disorder
•* CSF pleocytosis (WBC count ≥ 5/mm2)
•* MRI features suggestive of encephalitis
•* Reasonable exclusion of alternative causes
•3. Subjects or parent/legal representative willing to provide written informed consent

Exclusion Criteria

•1. Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
•2. Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
•3. Subject who has been diagnosed with IgA deficiency
•4. Subject who has renal disorder (creatinine clearance \< 10 ml/min) or requires dialysis
•5. Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
•6. Subject who has been diagnosed with immuonological competence or immunodeficiency
•7. Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
•8. Subject who has low heart condition (Congestive heart failure \>NYHA functional class Ⅱ: unstable coronary artery disease or myocardiac infarction within 3 months prior to screening)
•9. Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
•10. Females who are pregnant or breast feeding
+1 more criteria

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

November 20, 2019

Primary Completion Date

June 11, 2020

Completion Date

June 11, 2020

Last Updated

June 30, 2020

Enrollment

ACTUAL participants

Conditions

Autoimmune Encephalitis

Interventions

Immunoglobulin G

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

Inclusion Criteria

Exclusion Criteria

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