Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Autoimmune Encephalitis Clinical Trial

Official title:

Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03004209
• Other study ID #: 1607-120-777
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: February 6, 2018

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 6, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

Drug:
• Erythropoietin
three times per a week 100IU / k

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline modified Rankin Scale (mRS) at 12th week	Favorable outcome is an improvement of mRS score.	2nd week, 12th week
Secondary	Adverse effect	Common terminology criteria for adverse events (CTCAE) 4.0	2nd week, 4th week, 8th week, 12th week
Secondary	Quality of Life in Epilepsy Inventory (QOLIE) -31		2nd week, 4th week, 8th week, 12th week
Secondary	Mini-Mental State Examination (MMSE)		2nd week, 4th week, 8th week, 12th week