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WithdrawnNCT03004209Updated Sep 29, 2021

Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

A Phase 4 interventional study of Erythropoietin in Autoimmune Encephalitis, sponsored by Seoul National University Hospital. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Autoimmune Encephalitis

Keywords

  • Erythropoietin
  • Autoimmune encephalitis
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In context

Encephalitis

283 studies on the registry are indexed under Encephalitis; 55 are open to participants now.

Browse Encephalitis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    EPO

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

    Drug: Erythropoietin

Interventions

  • DrugErythropoietin

    three times per a week 100IU / k

    Also known as: Epokine prefilled injection

06

What researchers measure

Primary outcomes

  1. Change from Baseline modified Rankin Scale (mRS) at 12th week

    Favorable outcome is an improvement of mRS score.

    Time frame: 2nd week, 12th week

Secondary outcomes

  1. Adverse effect

    Common terminology criteria for adverse events (CTCAE) 4.0

    Time frame: 2nd week, 4th week, 8th week, 12th week

  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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Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03004209
Lead sponsor
Seoul National University Hospital
Responsible party
Kon Chu (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 28, 2016
Start date
Dec 2016
Primary completion
Feb 6, 2018
Completion
Feb 6, 2018
Last update
Sep 29, 2021

Study contacts

Kon Chu, Ph.D
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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