Status:
TERMINATED
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome
Lead Sponsor:
Haukeland University Hospital
Conditions:
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Eligibility:
All Genders
18-66 years
Phase:
PHASE2
Brief Summary
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from B-cell deple...
Eligibility Criteria
Inclusion
- patients severely affected by chronic fatigue syndrome, in WHO performance status III or IV.
- age 18-66 years
- informed consent
Exclusion
- patients with fatigue, not fulfilling criteria for CFS
- pregnancy or lactation
- previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
- previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
- endogenous depression
- lack of ability to comply by the protocol
- multi-allergy with risk of serious drug reaction
- reduced renal function (creatinin \> 1.5 x upper normal limit \[UNL\])
- reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
- HIV positivity
- evidence of clinically significant infection
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01156922
Start Date
June 1 2010
End Date
April 1 2016
Last Update
March 4 2024
Active Locations (1)
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1
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, Norway, N-5021