Autoimmune EncephalitisPhase 2NCT04175522
Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:
A Phase 2 study testing Immunoglobulin G in people with Autoimmune Encephalitis, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- Immunoglobulin G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2019to 11 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
- Conditions
- Autoimmune Encephalitis
- Being tested
- Immunoglobulin G
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin GDrug
IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Investigational product(IP) Receives: Drug: Immunoglobulin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Secondary outcomes (6)
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)
Measured: 28 days
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)
Measured: 28 days
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)
Measured: 28 days
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)
Measured: 28 days
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)
Measured: 28 days
The relationship
The relationship between neurological scale
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 Nov 2019
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soon Tae Lee, MD, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175522
- Sponsor's protocol ID
- GC5107AE01
- Status last verified
- Jun 2020
- First submitted
- 21 Nov 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04175522
- Acronym / sponsor ID
- GC5107AE01
- Conditions
- Autoimmune Encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Immunoglobulin GInvestigational product(IP) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Subjects or parent/legal representative willing to provide written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin GIGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously. | Drug | Experimental |
Primary outcome
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)
6 secondary outcomes
Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)
Time frame: 28 days
Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)
Time frame: 28 days
Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)
Time frame: 28 days
Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)
Time frame: 28 days
Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)
Time frame: 28 days
The relationship
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soon Tae Lee, MD, Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunoglobulin G in people with Autoimmune Encephalitis, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.