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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 25, 2014
Last verified: March 2014

August 4, 2009
March 25, 2014
October 2008
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00953771 on ClinicalTrials.gov Archive Site
Time to Remission [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura
Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thrombotic Thrombocytopenic Purpura
Drug: Danazol
Danazol 60 mg PO will be initiated with plasma exchange at the time of enrollment.
Other Names:
  • Danazol
  • Plasma Exchange
  • Corticosteroids
Experimental: Danazol, Plasma Exchange, Corticosteroids.
Everyone will receive Danazol with plasma exchange and corticosteroids
Intervention: Drug: Danazol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Mala Varma, M.D. 212-523-7281 mvarma@chpnet.org
Contact: Tahir Mirzoyev 212-523-7289 tmirzoye@chpnet.org
United States
 
NCT00953771
055-08
No
Beth Israel Medical Center
Beth Israel Medical Center
St. Luke's - Roosevelt Hoapital Center
Principal Investigator: Mala Varma, M.D. St. Luke's-Roosevelt Hospital Center
Beth Israel Medical Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP