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

Inclusion criteria

• Male or female, aged more than 12 years.(adolescent or adult)
• 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
• Subjects or parent/legal representative willing to provide written informed consent

Exclusion criteria

• Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
• Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
• Subject who has been diagnosed with IgA deficiency
• Subject who has renal disorder (creatinine clearance < 10 ml/min) or requires dialysis
• Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
• Subject who has been diagnosed with immuonological competence or immunodeficiency
• Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
• 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)
• Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
• Females who are pregnant or breast feeding
• Subject who is considered by investigator to ineligible for the study.