EUCTR2016-003138-26-NL进行中（未招募）1 期
Influenza vaccination in patients with Myasthenia Gravis - Influenza vaccine in Myasthenia Gravis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MC
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males and females aged above 18 years at the time of the injection.
- •2.Patient with ocular or generalized AChR MG and
- •3.A positive serologic test for AChR antibodies > 0.5 nmol/l in the past
- •4.Patient with prednisone dose lower than 30mg and stable (dose +/- 5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged.
- •5.A healthy control above 18 years at the time of injection with no immunosuppressive medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.MG patients with a severe form of MG (Grade 4 or 5 based on MGFA classification).
- •2.Myasthenic crisis in the last 3 months
- •3.Presence of a thymoma.
- •4.Planned thymectomy during the study period or within 12 months prior of the tetanus toxoid booster immunization.
- •5.Any confirmed or suspected immunosuppressive or immunodeficient condition not related to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
- •6.History or evidence of administration of immunoglobulins within 3 months prior to the tetanus revaccination.
- •7.History or evidence of plasmapheresis within 3 months prior to the tetanus revaccination.
- •8.At high risk for aspiration.
- •9.Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
- •10.History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •11.History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
- •12.Severe hepatic, renal or cardiac insufficiency.
- •13.Major congenital defects or serious chronic illness other than MG.
- •14.Pregnancy or desire to become pregnant during the study.
- •15.Use of vitamin-K antagonist or new anti-coagulants (NOACS)
- •16.The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
- •17.The investigator can exclude patients for this trial which are deemed not suitable for any reason.
研究者
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