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

This study is currently recruiting participants.
Verified February 2013 by Beth Israel Medical Center
Sponsor:
Collaborator:
St. Luke's - Roosevelt Hoapital Center
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00953771
First received: August 4, 2009
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Thrombotic Thrombocytopenic Purpura
 Drug: Danazol
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:

MedlinePlus related topics: Steroids
Drug Information available for: Danazol
U.S. FDA Resources

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: 30 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Remission [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Danazol, Plasma Exchange, Corticosteroids.
Everyone will receive Danazol with plasma exchange and corticosteroids
 Drug: Danazol
Danazol 60 mg PO will be initiated with plasma exchange at the time of enrollment.
Other Names:
  • Danazol
  • 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 on 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953771

Contacts
Contact: Mala Varma, M.D. 212-523-7281 mvarma@chpnet.org
Contact: Tahir Mirzoyev 212-523-7289 tmirzoye@chpnet.org

Locations
United States, New York
St. Luke's - Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Mala Varma, M.D.     212-523-7281     mvarma@chpnet.org    
Contact: Tahir Mirzoyev     212-523-7289     tmmirzoye@chpnet.org    
Principal Investigator: Mala Varma, M.D.            
Sponsors and Collaborators
Beth Israel Medical Center
St. Luke's - Roosevelt Hoapital Center
Investigators
Principal Investigator: Mala Varma, M.D. St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00953771     History of Changes
Other Study ID Numbers: 055-08
Study First Received: August 4, 2009
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
TTP
Thrombotic Thrombocytopenic Purpura

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Thrombosis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
 Immune System Diseases
Thrombophilia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013