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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00107913 |
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Date of registration:
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11/04/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
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Scientific title:
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Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura |
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Date of first enrolment:
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September 2001 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00107913 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Mary Ann Ostroske, RN |
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Address:
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Telephone:
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504-894-7115 |
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Email:
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mostroske1@salco.net |
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Affiliation:
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Name:
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Thomas M Cosgriff, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hematology and Oncology Specialists |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Thrombocytopenia with bone marrow findings showing normal or increased numbers of
megakaryocytes.
- Failure to respond to initial treatment with steroids, IV immune globulin,
splenectomy and post splenectomy steroids.
- Platelet count of 30,000 or less.
- Performance status score of 2 or less.
- Adequate organ function: *bilirubin< 2; *AST < 3 times normal; *creatinine < 2.
- No prior treatment with anthracycline or chemically related drugs.
Exclusion Criteria:
- Pregnant or lactating women.
- Presence of a malignancy other than basal cell carcinoma of the skin.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Autoimmune Thrombocytopenic Purpura
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Intervention(s)
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Drug: Doxil
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Primary Outcome(s)
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the primary outcome would be a platelet response, with a return of platelet count to normal
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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