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

NCT04175522 | Completed Phase 2

• 1 other identifier: GC5107AE01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)

  28 days

• Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)

  28 days

• Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)

  28 days

• Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)

  28 days

• Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)

  28 days

Study Arms (1)

Experimental

EXPERIMENTAL

Investigational product(IP)

Drug: Immunoglobulin G

Interventions

Immunoglobulin G DRUG

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

Experimental

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects or parent/legal representative willing to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Interventions

Immunoglobulin G

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Soon Tae Lee, MD, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: November 20, 2019
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

KR (1)