Safety study of Bacille-Calmette-Guerin (BCG) for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy(MADSAM).

Sydney Local Health District0 个研究点目标入组 20 人开始时间: 2018年11月28日最近更新: 2019年7月15日

试验速览

暂无简介。

•1. Fulfill EFNS criteria for definite or probable MMN or definite or probable atypical CIDP - MADSAM not benefitting from corticosteroids (no change or worsening)
•2. Untreated or treatment with intravenous immunoglobulin and/or plasma exchange (MADSAM) acceptable

•-Hyperergic on Mantoux reaction (induration greater than or equal to 5mm)
•-Active or previously treated tuberculosis
•-Current antituberculous therapy
•-Active serious infection as determined by the treating clinician. If in doubt discuss with the safety committee. A patient can also be reconsidered at a later date.
•-Previous serious adverse event to BCG
•-Concurrent BCG use for other purpose (including intravesical use)
•-Significant leukopaenia i.e. lymphocytes < 1.0, neutrophils < 1.0
•-HIV infection (serology within the last 12 months)
•-Known congenital or other immunodeficiency
•-Recent immunosuppressive medication including oral corticosteroids in the previous 2 months or rituximab or cyclophosphamide in the previous 12 months, or other antiproliferative agent in the previous 6 months, or other immunosuppressive agent used in combination or separately that is deemed by the treating physician to contribute to a significant immunocompromised state
•-Any other condition in the opinion of the local investigator that could increase patient risk by participation in the study
•-Serious comorbidity with a life expectancy of < 2 years
•-Pregnant (check pregnancy test in people capable of conception in the month before BCG injection)
•-Inability to provide consent or undertake assessments

发起方