Clinical Trial: Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: Beth Israel Medical Center

Current Primary Outcome: To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange. [ Time Frame: At 30 days ]

Original Primary Outcome: To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange. [ Time Frame: 30 day ]

Current Secondary Outcome: Time to Remission [ Time Frame: At 30 days ]

Original Secondary Outcome: Time to Remission [ Time Frame: every 3 months ]

Information By: Beth Israel Medical Center

Dates:
Date Received: August 4, 2009
Date Started: October 2008
Date Completion: December 2020
Last Updated: April 19, 2017
Last Verified: April 2017