Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

NCT ID: NCT03004209

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autoimmune Encephalitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EPO

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

Group Type OTHER

Erythropoietin

Intervention Type DRUG

three times per a week 100IU / k

Interventions

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Erythropoietin

three times per a week 100IU / k

Intervention Type DRUG

Other Intervention Names

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Epokine prefilled injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kon Chu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kon Chu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1607-120-777

Identifier Type: -

Identifier Source: org_study_id

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