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Daratumumab in ME/CFS
EU CTIS ID: 2024-512500-19-00
What this study is testing
To evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- Baseline Natural Killer (NK) cell count >130 x 10^6/L
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.