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

Autoimmune Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175522
• Other study ID #: GC5107AE01
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: June 11, 2020

Study information

• Verified date: June 2020
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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 ?: 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.

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

Drug:
• Immunoglobulin G
IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)	Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration)	28 days
Secondary	Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)	Change and improvment of mRS score 14 days and 28 days after IP administration compared with baseline(before IP administration)	28 days
Secondary	Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)	Change and improvment of Glasgow coma scale(GCS) 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)	28 days
Secondary	Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)	Change and improvment of Clinical Global Impression Scale-Severity 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)	28 days
Secondary	Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)	Change and improvment of Clinical Global Impression Scale-Improvement 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)	28 days
Secondary	Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)	Change and improvment of CASE score 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)	28 days
Secondary	The relationship	The relationship between neurological scale	28 days