Status:
TERMINATED
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Beth Israel Medical Center
Conditions:
Thrombotic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00953771
Start Date
October 1 2008
End Date
November 19 2015
Last Update
July 23 2024
Active Locations (1)
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1
Mount Sinai St. Luke's-Roosevelt
New York, New York, United States, 10019