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Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2005 by Hematology and Oncology Specialists.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107913
First Posted: April 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hematology and Oncology Specialists
April 11, 2005
April 12, 2005
December 9, 2005
September 2001
Not Provided
the primary outcome would be a platelet response, with a return of platelet count to normal
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).
Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Autoimmune Thrombocytopenic Purpura
Drug: Doxil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
April 2005
Not Provided

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00107913
HOS1
Not Provided
Not Provided
Not Provided
Not Provided
Hematology and Oncology Specialists
Not Provided
Principal Investigator: Thomas M Cosgriff, MD Hematology and Oncology Specialists
Hematology and Oncology Specialists
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP