Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An open label phase-II study with 6 infusions of cyclophosphamide 4 weeks apart. - Cyclophosphamide in ME/CFS

Department of Oncology, Haukeland University Hospital0 个研究点目标入组 40 人开始时间: 2014年10月22日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•-Patients with chronic fatigue syndrome according to Canadian inclusion criteria (2003).
•-Duration of disease at least 24 months.
•-Severe, moderate/severe, moderate and moderate/mild ME/CFS may be included.
•-Age 18-65 years.
•-Signed informed consent.
•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 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patients with fatigue, who do not comply with the diagnostic (”Canadian”) criteria for ME/CFS.
•-Disease duration < 24 months.
•-Patients with mild ME/CFS.
•-Patients with very severe ME/CFS (WHO function class IV), who are totally bedridden and in need of care.
•-Patients where the workup uncovers other pathology as a possible cause of symptoms.
•-Pregnancy or breast feeding. Positive pregnancy test.
•-Previous cancer (except basal cell carcinoma of the skin or carcinoma in situ or cervix dysplasia).
•-Previous long-term systemic treatment with immunosuppressive agents (Imurel, Sandimmun, Cellcept), except steroid treatments for e.g. obstructive lung disease or other autoimmune diseases like ulcerative colitis.
•-Serious endogenous (primary) depression.
•-Lack of ability to complete the study including follow-up.
•-Reduced kidney function (creatinine > 1,5 x reference area).
•-Reduced liver function (bilirubin > 1,5 x reference area, or transaminase > 1,5 x reference area).
•-Known HIV-positivity, previous hepatitis B or hepatitis C, or reason to suspect other ongoing and clinically relevant infection.

发起方

Department of Oncology, Haukeland University Hospital