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Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

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ClinicalTrials.gov Identifier: NCT03004209
Recruitment Status : Unknown
Verified December 2016 by Kon Chu, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

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
Autoimmune Encephalitis Drug: Erythropoietin 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017


Arm Intervention/treatment
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 Name: Epokine prefilled injection




Primary Outcome Measures :
  1. Change from Baseline modified Rankin Scale (mRS) at 12th week [ Time Frame: 2nd week, 12th week ]
    Favorable outcome is an improvement of mRS score.


Secondary Outcome Measures :
  1. Adverse effect [ Time Frame: 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 [ Time Frame: 2nd week, 4th week, 8th week, 12th week ]
  3. Mini-Mental State Examination (MMSE) [ Time Frame: 2nd week, 4th week, 8th week, 12th week ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004209


Contacts
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Contact: Keun Tae Kim, M.S +82-2-2072-3192 6k5upa@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kon Chu, Ph.D       stemcell.snu@gmail.com   
Contact: Keun Tae Kim, M.S.       6k5upa@gmail.com   
Principal Investigator: Kon Chu, MD, PhD.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Kon Chu, Ph.D Seoul National University Hospital

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Responsible Party: Kon Chu, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03004209     History of Changes
Other Study ID Numbers: 1607-120-777
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kon Chu, Seoul National University Hospital:
Erythropoietin
Autoimmune encephalitis

Additional relevant MeSH terms:
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Encephalitis
Hashimoto Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroiditis, Autoimmune
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Epoetin Alfa
Hematinics