EUCTR2022-000281-18-NO
Active, not recruiting
Phase 1
A pilot study using subcutaneous injections of the anti-CD38 antibody daratumumab in six patients with moderate to severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Resetting the humoral immune response in ME/CFS.
Haukeland University Hospital, Dept. of Oncology and Medical Physics0 sites10 target enrollmentFebruary 7, 2022
ConditionsMyalgic Encephalomyelitis/Chronic Fatigue SyndromeMedDRA version: 20.1Level: LLTClassification code 10028414Term: Myalgic encephalomyelitisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsDarzalex
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Sponsor
- Haukeland University Hospital, Dept. of Oncology and Medical Physics
- 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 (2003\) (1\);moderate (mainly housebound) to severe (mainly bedridden) disease.
- •Age 18 to 65 years.
- •Signed informed consent.
- •Duration of ME/CFS disease at least two years.
- •The ME/CFS disease should have a defined onset, e.g. after an initial infection or other immunological trigger.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Chronic fatigue conditions not fulfilling Canadian consensus criteria.
- •Age under 18 or over 65 years.
- •Mild or mild\-to moderate ME/CFS.
- •Very severe ME/CFS, where patient is unable to travel to the hospital for intervention and assessments.
- •Participation in a clinical trial with intervention aimed at ME/CFS during the last two years.
- •Endogenous depression.
- •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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