Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
The purpose of the study is to find out if administration of Danazol with plasma exchange and corticosteroids will reduce the number of plasma exchanges required to control Thrombotic Thrombocytopenic Purpura.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura|
- To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange. [ Time Frame: 30 day ] [ Designated as safety issue: No ]
- Time to Remission [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Danazol, Plasma Exchange, Corticosteroids.
Everyone will receive Danazol with plasma exchange and corticosteroids
Danazol 60 mg PO will be initiated with plasma exchange at the time of enrollment.
Danazol is a synthetic steroid hormone structurally resembling a group of natural hormones (androgens)found in the body. Danazol has immune modifying activity and is effective in treatment of blood disorders with low platelet counts such as idiopathic thrombocytopenic purpura (however FDA has not yet approved danazol for this disorder). A study of Danazol on conjunction with plasma exchange for thrombotic thrombocytopenic purpura showed that Danazol decreased the number of plasma exchanges required by approximately 80% and reduced the time needed to control the disease. It's not clear how Danazol works in TTP. It is not approved by the FDA for the treatment of TTP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953771
|Contact: Mala Varma, M.D.||firstname.lastname@example.org|
|Contact: Tahir Mirzoyevemail@example.com|
|United States, New York|
|St. Luke's - Roosevelt Hospital Center||Recruiting|
|New York, New York, United States, 10019|
|Contact: Mala Varma, M.D. 212-523-7281 firstname.lastname@example.org|
|Contact: Tahir Mirzoyev 212-523-7289 email@example.com|
|Principal Investigator: Mala Varma, M.D.|
|Principal Investigator:||Mala Varma, M.D.||St. Luke's-Roosevelt Hospital Center|