None listed
Conditions
Brief summary
Patients with ITP have reduced numbers of platelets in their blood, which makes them at risk of bleeding, which may be severe. The reduced platelets are due to them being destroyed by the patient’s own immune system (autoimmune). Treatment of this usually involves the use of broadly acting drugs to reduce this immune reaction. Drugs such as prednisone are often effective but have significant side effects. A new class of drug provides more targeted treatment with fewer side effects. The drug rituximab was developed to treat patients with cancer of the cells of the immune system and the dose used is high. This trial uses rituximab, which has been shown to be effective at high dose, in a lower dose schedule. There is some data to suggest that the lower dose may be sufficient and this study seeks to confirm this by treating a statistically sufficient numbers of patients to draw firm conclusions. Patients eligible for the study will have severe ITP which has not responded satisfactorily to standard therapy. Assuming the results of the lower dose are satisfactory the benefits of therapy being cheaper, and the risk of side effects being reduced, would make this treatment an advance in the care of patients with ITP.
Interventions
A 100mg dose of rituximab is given intra-venously weekly for 4 weeks in total
Sponsors
Florence Peterson Fund
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Aged over 18 years Refractory ITP defined as a platelet count of <30 despite 8 weeks of standard ITP therapy ITP that has relapsed post splenectomy
Exclusion criteria
Aged <18 years ITP diagnosed <8 weeks Prior Rituximab therapy HIV infection SLE associated Lymphoproliferative associated
Outcome results
None listed