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

June 28, 2020 updated by: Green Cross Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Investigational product(IP)
Drug: Immunoglobulin G
IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)
Time Frame: 28 days
Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration)
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)
Time Frame: 28 days
Change and improvment of mRS score 14 days and 28 days after IP administration compared with baseline(before IP administration)
28 days
Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)
Time Frame: 28 days
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
Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)
Time Frame: 28 days
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
Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)
Time Frame: 28 days
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
Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)
Time Frame: 28 days
Change and improvment of CASE score 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)
28 days
The relationship
Time Frame: 28 days
The relationship between neurological scale
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Green Cross Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soon Tae Lee, MD, Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GC5107AE01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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