Status:
TERMINATED
Study of the Effectiveness of Rituximab in Adults With Chronic and Severe Immune Thrombocytopenic Purpura and Candidate for a Splenectomy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Etablissement Français du Sang
Conditions:
Autoimmune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to evaluate the clinical effectiveness of the rituximab at the adults with a chronic immune thrombocytopenic purpura (\>=6 months of evolution) and severe (platelets \<= 30x1...
Detailed Description
Adults immune thrombocytopenic purpura has an evolution which is generally chronic defined by the persistence of the thrombocytopenia 6 months after the diagnosis. The treatment is then based on the s...
Eligibility Criteria
Inclusion
- Platelets \<= 30x109/L in the absence of agglutinat
- Evolution of the PTAI \>= 6 months starting from the date of the diagnosis
- Myélogramme normal and rich in mégacaryocytes
- Age \>=18 years
- Among patients at which the treatments prescribed before (and in particular corticoids or intravenous immunoglobulins) did not have any effectiveness, even transitory, the diagnosis of ITP will have to be confirmed by an isotopic study of the 1/2 life of the plates.
Exclusion
- Refusal of informed and enlightened assent written.
- Intermittent ITP defined by which has occurred of transitory periods of remissions variable length of the thrombocytopenia.
- Sick splenectomized whatever is the reason
- Splénomégalie
- Absence of vaccination against the pneumococcus
- Absence of vaccination against Haemophilus influenzae
- Previous of treatment by the rituximab
- Administration of a treatment known as active during the ITP other than corticoids in the 30 days which precede inclusion
- CIVD and/or weakens haemolytic with schizocytes
- Serology VIH or positive VHC, Ag positive HBs
- Rate of ALAT or ASAT higher than twice the higher limit of the normal of the laboratory
- Associated autoimmune anomalies:
- Anti DNA and/or anti ECT (ENA) and/or anti Ro (SSA)
- The presence isolated from antibody anti cores (nuclear anti factors) is not a criterion of exclusion.
- Anticoagulant circulating of lupic type and/or antibody anticardiolipines with antecedent of thrombosis or spontaneous miscarriages with repetition (their isolated presence is not a criterion of exclusion)
- Other autoimmune diseases: lupus (with at least 4 criteria of the ACR), polyarthrite chronic evolutionary, disease of Biermer, affected thyroid, weakens haemolytic autoimmune.
- Pregnant woman, breast feeding, woman in genital working life in the effective absence of contraception throughout treatment and 12 month after stop of the treatment.
- Evolutionary or previous cancer of malignant hemopathy
- Over-sensitiveness with murine proteins
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00225875
Start Date
September 1 2003
End Date
July 1 2007
Last Update
October 27 2005
Active Locations (1)
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1
Hôpital Henri Mondor
Créteil, France, 94000