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

NCT ID: NCT04175522

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2020-06-11

Brief Summary

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

Conditions

Autoimmune Encephalitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Investigational product(IP)

Group Type: EXPERIMENTAL

Immunoglobulin G

Intervention Type: DRUG

IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.

Interventions

Immunoglobulin G

IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.

Intervention Type: DRUG

Eligibility Criteria

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

11. Subject who is considered by investigator to ineligible for the study.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soon Tae Lee, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GC5107AE01

Identifier Type: -

Identifier Source: org_study_id