Status:
COMPLETED
Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Thrombotic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multicentric non-randomized phase II opened prospective study (10 centres involved). Primary endpoint: * To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patient...
Detailed Description
Duration of the study: 3 years and 2 months, including 1 year of inclusion and 2 years of participation for the patient. Experimental plan: Patients fulfilling the inclusion criteria of the study w...
Eligibility Criteria
Inclusion
- Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia \<50 G/L, and mild or no renal failure (Serum creatinine \< 150 µmol/L),
- negative Beta HCG and ongoing contraception during treatment and during the 24 months following the last infusion of rituximab,
- refractory TTP (after 4 days of standard treatment)
- \> 18 year old
- and signed written informed consent.
Exclusion
- Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150 micromol/L),
- TTP associated with another condition (HIV infection, cancer and/or chemotherapy, transplantation),
- previous treatment with vincristine or cyclophosphamide or other immunomodulatory drugs (except steroids), within 2 months before inclusion ;
- ongoing or planned pregnancy, lactation
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00907751
Start Date
May 1 2010
End Date
August 1 2013
Last Update
February 27 2014
Active Locations (1)
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1
Saint-Antoine Hospital, Hematology
Paris, France, 75012