A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura.

niversity College London0 个研究点目标入组 40 人开始时间: 2005年11月4日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•-Patients >18 years and < 65 years who present with an acute episode of TTP.
•-Evidence of microangiopathic haemolytic anaemia.
•-Thrombocytopenia with a normal clotting screen.
•-Raised lactate dehydrogenase (one and a half times above upper normal).
•-Patients without neurological dysfunction able to give informed consent.
•-Patients of reproductive age [must avoid pregnancy for 12 months and or normalised B cell function after receiving Rituximab. Oestrogen containing oral contraceptive pills and the morning after pills should be avoided in female TTP patients].
•-Patients with an acute deterioration in neurological function which may include encephalopathy, such as altered personality, problems with short term memory and coma can be included when consent has been given by next of kin or from the appropriate legal representative.
•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
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•-All female subjects who are knowingly pregnant or breast feeding or do not use an adequate form of contraception [the effects on the foetus and newborn have not yet been fully established so Rituximab should be avoided in these groups. Male patients receiving Rituximab should ensure adequate contraception for 12 months following treatment.]
•-Patients who are HIV positive [which does not appear to be antibody mediated, would be unlikely to benefit from Rituximab].
•-Patients with childhood TTP.
•-Patients who have haemolytic uraemic syndrome [which is not associated with reduced ADAMTS 13 levels].
•-Patients who are Post bone marrow transplant-either autologous or allogeneic
•-Patients with a medical or long term psychiatric condition which, in the opinion of the investigator, contraindicates the patients’ participation into the trial.
•-Previous or concurrent malignancies at other sites, with exception of appropriately treated localized epithelial or cervical cancer. Patients with a history of cured tumours may be entered (> 5 years).

发起方

niversity College London