JPRN-UMIN000038903已完成2 期
Efficacy and Safety of OCH-NCNP1 in patients with Relapsing Multiple Sclerosis - Phase II clinical trial of OCH-NCNP1
ational Center of Neurology and Psychiatry0 个研究点目标入组 30 人开始时间: 2019年12月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Subject with MS patients meeting any of the following criteria must not be enrolled in the study: 1. Diagnosed as Neuromyelitis Optica 2. Women who are pregnant or lactating 3. Patients with contraindications for MRI 4. Patients who are allergic to Gd-contrast medium 5. History of liver diseases or liver transplantation 6. Liver dysfunction in the screening test and baseline physical examination 7. History of cancer in the last five years 8. Negative for herpes zoster virus antibody 9. Positive for Syphilis serum reaction 10. Positive for Beta-glucan or positive for T-spot 11. Positive for Anti-Aquaporin 4 antibody 12. History of HIV infection 13. History of HBV or HCV infection 14. History of Transplantation 15. Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication. 16. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication 17. Lymphocyte number < 600 /mm3 in peripheral blood 18. Current diagnosed or suspected infectious diseases 19. Compromised Patients 20. Inflammatory Bowel disease 21. Subjects with prolongation of QT/QTc interval 22. History or have risk of torsade de pointes 23. Taking the medicine which has risk of prolongation of QT/QTc interval 24. History of severe allergy of medicine or food 25. History or current of drug/ alcohol addiction 26. Bronchial Asthma 27. Epilepsy Other protocol-defined exclusion criteria may apply
研究者
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