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| ID | Type | Description | Link |
|---|---|---|---|
| 055-08 | Other Identifier | Beth Israel Medical Center |
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low enrollment
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| Name | Class |
|---|---|
| Beth Israel Medical Center | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danazol, Plex, Steroids | Experimental | Everyone will receive Danazol with plasma exchange and corticosteroids |
|
| Historic Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danazol | Drug | Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Plasma Exchanges | The total number of plasma exchanges performed after initiation of the first plasma exchange. | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Remission | up to 30 days | |
| Length of Stay | up to 30 days | |
| Number of Participants With Complete and Continuous Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilan Shapira, M.D. | Mount Sinai St. Luke's-Roosevelt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai St. Luke's-Roosevelt | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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Subjects were not enrolled to the control group; data was retrospectively collected by viewing the charts of 20 patients who received Plasma Exchange
Study opened for patient recruitment on Oct 29, 2008 at Beth Israel Medical Center and St. Luke's-Roosevelt Hospital Center. The study was closed by the IRB on 10/12/2018 due to low enrollment. The last date of study data collection was 11/19/2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Danazol, Plex, Steroids | Everyone will receive Danazol with plasma exchange and corticosteroids Danazol: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment. |
| FG001 | Historic Control | The subjects were not enrolled to the control group; data was retrospectively collected by viewing the charts of 20 patients who received Plasma Exchange |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The subjects were not enrolled to the control group; outcome data was retrospectively collected by viewing the charts of 20 patients who received Plasma Exchange. Baseline data was not collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Danazol, Plex, Steroids | Everyone will receive Danazol with plasma exchange and corticosteroids Danazol: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment. |
| BG001 | Historic Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Plasma Exchanges | The total number of plasma exchanges performed after initiation of the first plasma exchange. | Posted | Mean | Standard Deviation | exchanges | up to 30 days |
|
12 years
Adverse events not collected for the historic control arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Danazol, Plex, Steroids | Everyone will receive Danazol with plasma exchange and corticosteroids Danazol: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ilan Shapira | Mount Sinai Beth Israel | 212-844-8948 | Ilan.Shapira@mountsinai.org |
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| ID | Term |
|---|---|
| D011697 | Purpura, Thrombotic Thrombocytopenic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D003613 | Danazol |
| D010951 | Plasma Exchange |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| At 2 Years |
| Time to Relapse | up to 12 years |
| Number of Participants With Relapses | Number of participants with relapses | up to 12 years |
| Number of Relapses | Number of relapses | up to 12 years |
The subjects were not enrolled to the control group; data was retrospectively collected by viewing the charts of 20 patients who received Plasma Exchange |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Time to Remission | Posted | Mean | Standard Deviation | days | up to 30 days |
|
|
|
| Secondary | Length of Stay | Posted | Mean | Standard Deviation | days | up to 30 days |
|
|
|
| Secondary | Number of Participants With Complete and Continuous Response Rate | Two of the 20 historical controls did not have data for hospitalization days or time to remission, therefore computed complete response rates among the 18 patients for whom full data was available. | Posted | Count of Participants | Participants | At 2 Years |
|
|
|
| Secondary | Time to Relapse | Posted | Median | Full Range | months | up to 12 years |
|
|
|
| Secondary | Number of Participants With Relapses | Number of participants with relapses | Posted | Count of Participants | Participants | up to 12 years |
|
|
|
| Secondary | Number of Relapses | Number of relapses | Posted | Number | relapses | up to 12 years |
|
|
|
| 1 |
| 9 |
| 2 |
| 9 |
| 0 |
| 9 |
| EG001 | Historic Control | The subjects were not enrolled to the control group; data was retrospectively collected by viewing the charts of 20 patients who received Plasma Exchange | 0 | 0 | 0 | 0 | 0 | 0 |
| hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D019851 | Thrombophilia |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |