CTIS2024-512500-19-00
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Sponsor
- Helse Bergen HF
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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