Status:
COMPLETED
The Use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura (TTP)
Lead Sponsor:
University College, London
Conditions:
Thrombotic Thrombocytopenic Purpura (TTP)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
TTP is a rare and serious blood disorder, characterized by the formation of small clots (micro thrombi) within the circulation and can be fatal. The formation of blood clots occurs primarily in the sm...
Detailed Description
This is multi-centre study within the South East England (SEE) Thrombotic Thrombocytopenic Purpura (TTP) study group, primarily involving tertiary centres with expertise in treating TTP, apheresis uni...
Eligibility Criteria
Inclusion
- 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 time 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.
Exclusion
- All female subjects who are knowingly pregnant or breast feeding or do not use an adequate form of contraception (the effect 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 (HUS) (which is not associated with reduced ADAMTS 13 levels)
- Patients who are post bone marrow transplant - either autologous or allogeneic
- Patients wiht 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).
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00937131
Start Date
March 1 2006
End Date
June 1 2010
Last Update
May 16 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
2
St Thomas Hosptial
London, United Kingdom, SE1 7EH
3
University College London Hospitals
London, United Kingdom, W1