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

• Status: Terminated
• Trial end date: 2015-10-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Medical Center; Icahn School of Medicine at Mount Sinai
• Collaborators: Beth Israel Medical Center; Icahn School of Medicine at Mount Sinai
• Treatments: Danazol

Criteria

Inclusion Criteria:

• TTP with platelets less than 10,000 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.