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

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ClinicalTrials.gov Identifier: NCT00953771
Recruitment Status : Recruiting
First Posted : August 6, 2009
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):

Study Description
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 Purpura (TTP).

Condition or disease Intervention/treatment Phase
Thrombotic Thrombocytopenic Purpura Drug: Danazol Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura
Study Start Date : October 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Time to Remission [ Time Frame: At 30 days ]

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953771

Contact: Ilan Shapira, M.D. 212-844-8948 Ilan.Shapira@mountsinai.org
Contact: Tahir Mirzoyev 212-523-7289 tmirzoye@chpnet.org

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    tmmirzoye@chpnet.org   
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
ClinicalTrials.gov Identifier: NCT00953771     History of Changes
Other Study ID Numbers: 055-08
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 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