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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Beth Israel Medical Center
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Beth Israel Medical Center Identifier:
First received: August 4, 2009
Last updated: April 19, 2017
Last verified: April 2017
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).

Condition Intervention Phase
Thrombotic Thrombocytopenic Purpura
Drug: Danazol
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura

Resource links provided by NLM:

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange. [ Time Frame: At 30 days ]

Secondary Outcome Measures:
  • Time to Remission [ Time Frame: At 30 days ]

Other Outcome Measures:
  • Length of Stay [ Time Frame: At 30 days ]
  • Complete and Continuous Response Rate [ Time Frame: At 2 Years ]

Estimated Enrollment: 25
Study Start Date: October 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Danazol, Plex, Steroids
Everyone will receive Danazol with plasma exchange and corticosteroids
Drug: Danazol
Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
Other Names:
  • Plasma Exchange
  • Corticosteroids

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00953771

Contact: Ilan Shapira, M.D. 212-844-8948
Contact: Tahir Mirzoyev 212-523-7289

United States, New York
Mount Sinai St. Luke's-Roosevelt Recruiting
New York, New York, United States, 10019
Contact: Ilan Shapira, M.D.         
Contact: Tahir Mirzoyev    212-523-7289   
Principal Investigator: Ilan Shapira, M.D.         
Sponsors and Collaborators
Beth Israel Medical Center
Icahn School of Medicine at Mount Sinai
Principal Investigator: Ilan Shapira, M.D. Mount Sinai St. Luke's-Roosevelt
  More Information

Responsible Party: Beth Israel Medical Center Identifier: NCT00953771     History of Changes
Other Study ID Numbers: 055-08
Study First Received: August 4, 2009
Last Updated: April 19, 2017

Keywords provided by Beth Israel Medical Center:
Thrombotic Thrombocytopenic Purpura

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017