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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00953771
Other study ID # GCO 16-2608
Secondary ID 055-08
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2008
Est. completion date November 19, 2015

Study information

Verified date January 2024
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date November 19, 2015
Est. primary completion date November 19, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - TTP with platelets less than 100,000 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Danazol
Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.

Locations

Country Name City State
United States Mount Sinai St. Luke's-Roosevelt New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Torri V, Friedman M, Shapira I, Patel AA, Yoe J, Shah VP, Mirzoyev T, Machuca M, Varma M. Phase II study of danazol with plasma exchange and corticosteroids for the treatment of thrombotic thrombocytopenic purpura. Blood (2023) 142 (Supplement 1): 4007.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Plasma Exchanges The total number of plasma exchanges performed after initiation of the first plasma exchange. up to 30 days
Secondary Time to Remission up to 30 days
Secondary Length of Stay up to 30 days
Secondary Number of Participants With Complete and Continuous Response Rate At 2 Years
Secondary Time to Relapse up to 12 years
Secondary Number of Participants With Relapses Number of participants with relapses up to 12 years
Secondary Number of Relapses Number of relapses up to 12 years
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