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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00953771
Recruitment Status : Terminated (low enrollment)
First Posted : August 6, 2009
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Beth Israel Medical Center
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE August 4, 2009
First Posted Date  ICMJE August 6, 2009
Last Update Posted Date December 10, 2018
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 14, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange. [ Time Frame: At 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange. [ Time Frame: 30 day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
Time to Remission [ Time Frame: At 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
Time to Remission [ Time Frame: every 3 months ]
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2015)
  • Length of Stay [ Time Frame: At 30 days ]
  • Complete and Continuous Response Rate [ Time Frame: At 2 Years ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
Official Title  ICMJE Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombotic Thrombocytopenic Purpura
Intervention  ICMJE Drug: Danazol
Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
Other Names:
  • Plasma Exchange
  • Corticosteroids
Study Arms  ICMJE Experimental: Danazol, Plex, Steroids
Everyone will receive Danazol with plasma exchange and corticosteroids
Intervention: Drug: Danazol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 6, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2009)
25
Actual Study Completion Date  ICMJE October 14, 2015
Actual Primary Completion Date October 14, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00953771
Other Study ID Numbers  ICMJE GCO 16-2608
055-08 ( Other Identifier: Beth Israel Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Beth Israel Medical Center
Investigators  ICMJE
Principal Investigator: Ilan Shapira, M.D. Mount Sinai St. Luke's-Roosevelt
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2018

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