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

Helse Bergen HF0 个研究点目标入组 10 人开始时间: 2024年6月19日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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

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