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Sponsors and Collaborators: |
Weill Medical College of Cornell University Genentech |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00251277 |
The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP). This includes evaluating the rate and type of treatment failure.
Condition | Intervention | Phase |
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Thrombotic Thrombocytopenic Purpura |
Drug: Rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura |
Estimated Enrollment: | 12 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be included in the trial based on the following criteria:
Exclusion Criteria:
Patients will be excluded from the trial based on the following criteria:
Contact: James B Bussel, M.D. | 2120-746-3474 | jbussel@med.cornell.edu |
United States, New York | |
Weill Medical College of Cornell University/New York Presbyterian Hospital | Recruiting |
New York, New York, United States, 10021 | |
Contact: James B Bussel, M.D. 212-746-3474 jbussel@med.cornell.edu |
Principal Investigator: | James B Bussel, M.D. | Weill Medical College of Cornell University |
Responsible Party: | Weill Cornell Medical College ( James Bussel ) |
Study ID Numbers: | 0409007463 |
Study First Received: | November 7, 2005 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00251277 |
Health Authority: | United States: Food and Drug Administration |
Thrombotic Thrombocytopenic Purpura TTP Hematology |
Purpura Rituximab Hematologic Diseases Thrombophilia Blood Coagulation Disorders Blood Platelet Disorders Vascular Diseases Hemostatic Disorders Purpura, Thrombotic Thrombocytopenic |
Purpura, Thrombocytopenic Thrombosis Thrombotic thrombocytopenic purpura, acquired Thrombocytopathy Signs and Symptoms Embolism and Thrombosis Thrombocytopenia Embolism |
Skin Manifestations Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antirheumatic Agents Pharmacologic Actions |