Thrombotic Thrombocytopenic Purpura Clinical Trial
— TTPOfficial title:
Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura
Verified date | January 2024 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai St. Luke's-Roosevelt | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Beth Israel Medical Center |
United States,
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.
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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