Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

Seoul National University

Status and phase: Withdrawn; Phase 4

Conditions: Autoimmune Encephalitis

Treatments: Drug: Erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03004209

1607-120-777

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

EPO

Other group

Description:

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

Treatment:

Drug: Erythropoietin