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Phase II study to determine if Danazol is an Anti-D agent when used in combination with Anti-D for the treatment of ITP
Principal Investigator:   Mala Varma, MD
Co-investigators:   Michael Grossbard MD, Ibrahim Nakhoul MD, Peter Kozuch MD, IIan Shapira MD, Bruce Culliney MD, Ralph Zalusky MD
Time frame of study:   Ongoing
Time frame of participation:   2 years
Number of participants needed:   26
Location of Study:  

St. Luke's-Mount Sinai Roosevelt
Mount Sinai Beth Israel
Office of Clinical Research
317 East 17th Street
New York, NY

Contact Name, Number & Email:   Mala Varma MD, 212-844-6286
mvarma@chpnet.org

Summary:
Mount Sinai St. Luke's, Mount Sinai Roosevelt, and Mount Sinai Beth Israel's Clinical Research Office is conducting a research study for the combination of anti-Rh(D) and danazol in patient with Immune Thrombocytopenic Purpura (ITP). This study will determine if danazol is an anti-Rh(D)-sparing agent and that the addition of danazol to anti-Rh(D) may decrease the requirement for anti-Rh (D) and even conclude the need for continued anti-Rh(D) after one year.

Criteria for Participation:
Patients diagnosed with Immune thrombocytopenic purpura at least 18 years of age who have platelets less than 30,000/µl.

Benefit of Participation:
There may or may not be direct medical benefit to you. We hope the information learned from this study will benefit other subjects with ITP in the future.