2024-512500-19-00招募中2 期
A pilot study using subcutaneous injections of the anti-CD38 antibody daratumumab in patients with moderate to severe Myalgic Encephalomyelitis /Chronic Fatigue Syndrome (ME/CFS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Safety and tolerability as measured by treatment-emergent adverse events.
研究概览
简要总结
To evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
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
- •Baseline Natural Killer (NK) cell count >130 x 10^6/L
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
结局指标
主要结局
Safety and tolerability as measured by treatment-emergent adverse events.
Safety and tolerability as measured by treatment-emergent adverse events.
次要结局
- Changes in SF36 domain scores including Physical Function and Bodily pain, from the baseline/run-in period through 40 weeks' follow-up from start of intervention
- Changes in DSQ-SF scores, from the baseline/run-in period through 40 weeks' follow-up from start of intervention
- Changes in patient-reported physical function, from the baseline/run-in period through 40 weeks' follow-up from start of intervention
- Changes in steps per 24 hours, from the baseline/run-in period through 40 weeks' follow-up from start of intervention
研究者
Øystein Fluge
Scientific
Helse Bergen HF
研究点 (2)
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