Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombo… (NCT00953771) | Clinical Trial Compass
TerminatedPhase 2
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
Stopped: low enrollment
United States9 participantsStarted 2008-10
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.