Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
- Registration Number
- NCT00953771
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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 Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- TTP with platelets less than 100,000 and microangiopathic hemolytic anemia
- Age greater than 18 and less than 60
- LDH > 2x upper limit of normal
- PT and PTT normal
- Patients must give signed informed consent
- Pre-menopausal woman must have negative pregnancy test.
- TTP not related to underlying cancer, treatment of cancer or transplantation.
- TTP not associated with drugs.
- LFTs AST/ALT > 2x upper limit of normal
- Hepatitis B and Hepatitis C infection.
- HIV with active opportunistic infections
- Acute or chronic Disseminated Intravascular Coagulation (DIC), defined as D-dimer 8ug/ml and fibrinogen<100 mg/dl
- TTP related to drugs, malignancy and transplantation.
- Pregnancy
- Concurrent other investigational drug use during this study.
- Porphyria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Danazol, Plex, Steroids Danazol Everyone will receive Danazol with plasma exchange and corticosteroids
- Primary Outcome Measures
Name Time Method Number of Plasma Exchanges up to 30 days The total number of plasma exchanges performed after initiation of the first plasma exchange.
- Secondary Outcome Measures
Name Time Method Time to Remission up to 30 days Number of Participants With Relapses up to 12 years Number of participants with relapses
Time to Relapse up to 12 years Number of Relapses up to 12 years Number of relapses
Number of Participants With Complete and Continuous Response Rate At 2 Years Length of Stay up to 30 days
Trial Locations
- Locations (1)
Mount Sinai St. Luke's-Roosevelt
🇺🇸New York, New York, United States