Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225875
Status:
TERMINATED
Last Update Posted:
2005-10-27
First Post:
2005-09-20
Brief Title:
Study of the Effectiveness of Rituximab in Adults With Chronic and Severe Immune Thrombocytopenic Purpura and Candidate for a Splenectomy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation De lEfficacité Du Rituximab Mabthéra Chez lAdulte Atteint dUn Purpura thrombopénique Auto-Immun Chronique Et sévère Et Candidat à La splénectomie
Status:
TERMINATED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 30x109L and candidate to a splenectomy The objective is to obtain after a treatment by the rituximab a satisfactory response to one year defined by a number of platelets higher than 50x109L and at least 2 times superior with the persistent initial figure without treatment during one year after the end of the treatment
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 splenectomy which is proposed by the majority of the teams when the platelets are lower than 30x109L The splenectomy is effective at 70 to 80 of the patients whereas no medicamentous treatment makes it possible to obtain a comparable result Nevertheless it exposes to immediate post-operative complications and to a risk of mortal fulminant infections by encapsulated germs in particular the pneumococcus However its long-term effectiveness is discussed with a risk of relapse which would reach 50 for certain teams
The rituximab could be an alternative to the splenectomy because of its great frequency of effectiveness and its good tolerance in the short and medium term None the medicamentous treatments usually suggested in alternative to the splenectomy disulone danazol immunosuppressors indeed makes it possible to obtain an answer prolonged after the stop of therapeutic in a significant number of cases Moreover the use of the immunosuppressors such as the cyclophosphamide the azathioprine or the ciclosporine appears contestable at this stage of the disease because of potential severity their side effectsThe primary endpoint is satisfactory response to one year defined by a figure of plates 50x109L and at least 2 times superior in the initial and persistent figure without treatment during one year after the stop of the treatment by rituximab Secondary objectives are incomplete response to one year defined by a figure of platelets 30x109L and 50x109L and at least twice the figure initial or 50x109L but lower than twice the persistent initial figure without treatment during one year after the end of the treatment by rituximab Splenectomy at one year satisfactory Response to 2 years incomplete Response to 2 years Splenectomies at 2 years Tolerance of the treatment
The rituximab could be an alternative to the splenectomy because of its great frequency of effectiveness and its good tolerance in the short and medium term None the medicamentous treatments usually suggested in alternative to the splenectomy disulone danazol immunosuppressors indeed makes it possible to obtain an answer prolonged after the stop of therapeutic in a significant number of cases Moreover the use of the immunosuppressors such as the cyclophosphamide the azathioprine or the ciclosporine appears contestable at this stage of the disease because of potential severity their side effectsThe primary endpoint is satisfactory response to one year defined by a figure of plates 50x109L and at least 2 times superior in the initial and persistent figure without treatment during one year after the stop of the treatment by rituximab Secondary objectives are incomplete response to one year defined by a figure of platelets 30x109L and 50x109L and at least twice the figure initial or 50x109L but lower than twice the persistent initial figure without treatment during one year after the end of the treatment by rituximab Splenectomy at one year satisfactory Response to 2 years incomplete Response to 2 years Splenectomies at 2 years Tolerance of the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None