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Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Sponsor
Seoul National University Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03004209
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
14.2
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.

We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Feb 6, 2018
Actual Study Completion Date :
Feb 6, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: EPO

Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection

Drug: Erythropoietin
three times per a week 100IU / k
Other Names:
  • Epokine prefilled injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline modified Rankin Scale (mRS) at 12th week [2nd week, 12th week]

      Favorable outcome is an improvement of mRS score.

    Secondary Outcome Measures

    1. Adverse effect [2nd week, 4th week, 8th week, 12th week]

      Common terminology criteria for adverse events (CTCAE) 4.0

    2. Quality of Life in Epilepsy Inventory (QOLIE) -31 [2nd week, 4th week, 8th week, 12th week]

    3. Mini-Mental State Examination (MMSE) [2nd week, 4th week, 8th week, 12th week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinically diagnosed autoimmune encephalitis

    • Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)

    Exclusion Criteria:

    • Hemoglobin > 12g/dL

    • Hematochrit >36%

    • Thrombocytosis > 750K

    • AST or ALT > 120

    • HIV (+)

    • Allergic reaction upon erythropoietin

    • Uncontrolled hypertension

    • mRS before the autoimmune encephalitis > 3

    • Breast feeding or pregnancy

    • History of ischemic stroke or pulmonary thrombosis

    • Refuse to be enrolled

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Kon Chu, Ph.D, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kon Chu, Associate Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03004209
    Other Study ID Numbers:
    • 1607-120-777
    First Posted:
    Dec 28, 2016
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Kon Chu, Associate Professor, Seoul National University Hospital
    Erythropoietin
    Autoimmune encephalitis
    Additional relevant MeSH terms:
    Encephalitis
    Hashimoto Disease
    Epoetin Alfa

    Study Results

    No Results Posted as of Sep 29, 2021