Status:
COMPLETED
Drug Intervention in Chronic Fatigue Syndrome
Lead Sponsor:
Haukeland University Hospital
Conditions:
Chronic Fatigue Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy. The hypothesis is that at least a subset of CF...
Eligibility Criteria
Inclusion
- verified chronic fatigue syndrome (CDC-criteria)
- age \>18 and \<60 years
- informed consent
Exclusion
- pregnancy or lactation
- previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
- previous long-term use of immunosuppressive drugs
- previous exposure to rituximab
- endogenous depression
- multi-allergy with risk of serious drug reaction
- reduced renal function (creatinin \> 1.2 x UNL)
- reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
- known HIV infection
- signs of active viral infection by pretreatment investigations
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00848692
Start Date
June 1 2008
End Date
June 1 2010
Last Update
May 11 2021
Active Locations (1)
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1
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, Norway, N-5021