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 (TTP).
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 in 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
Mount Sinai St. Luke's-Roosevelt
New York, New York, United States
Number of Plasma Exchanges
The total number of plasma exchanges performed after initiation of the first plasma exchange.
Time frame: up to 30 days
Time to Remission
Time frame: up to 30 days
Length of Stay
Time frame: up to 30 days
Number of Participants With Complete and Continuous Response Rate
Time frame: At 2 Years
Time to Relapse
Time frame: up to 12 years
Number of Participants With Relapses
Number of participants with relapses
Time frame: up to 12 years
Number of Relapses
Number of relapses
Time frame: up to 12 years
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