CTIS2024-512500-19-00进行中（未招募）1 期
A pilot study using subcutaneous injections of the anti-CD38 antibody daratumumab in ten patients with moderate to severe Myalgic Encephalomyelitis /Chronic Fatigue Syndrome (ME/CFS) - KTS-9-2022
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- 18 至 64（—）
- 性别
- All
入选标准
- •ME/CFS according to Canadian consensus criteria; moderate to severe disease, Age 18 to 65 years, Signed informed consent, At least two years disease duration, Defined onset of ME/CFS, e.g. after infection
排除标准
- •Chronic fatigue conditions not fulfilling Canadian consensus criteria, Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection, Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix., Pregnancy or lactation, Inability to comply with protocol including follow-up, Endogenous depression, Age under 18 or over 65 years, Mild or mild-moderate ME/CFS, Very severe ME/CFS, Participation in clinical intervention trial aimed at ME/CFS within two years before inclusion, Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab, Known contraindication to daratumumab, Significant comorbidity with reduced organ function (kidney, liver, heart, pulmonary), Previous long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease
研究者
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