Trial · NCT00953771
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
NCT00953771, Phase 2, Terminated, Icahn School of Medicine at Mount Sinai; results first posted 2023-08-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP). Trials, record NCT00953771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953771
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
- NCT number
- NCT00953771
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Interventions
- Danazol
- First posted
- 2009-08-06
- Last updated
- 2024-07-23
- Results first posted
- 2023-08-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Plasma Exchanges | up to 30 days | The total number of plasma exchanges performed after initiation of the first plasma exchange. |
| 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 | up to 12 years | Number of participants with relapses |
| Secondary | Number of Relapses | up to 12 years | Number of relapses |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Plasma Exchanges | up to 30 days | exchanges | MEAN | |
| SECONDARY | Time to Remission | up to 30 days | days | MEAN | |
| SECONDARY | Length of Stay | up to 30 days | days | MEAN | |
| SECONDARY | Number of Participants With Complete and Continuous Response Rate | At 2 Years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Relapse | up to 12 years | months | MEDIAN | |
| SECONDARY | Number of Participants With Relapses | up to 12 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Relapses | up to 12 years | relapses | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Plasma Exchanges | Danazol, Plex, Steroids | 14.8 | Standard Deviation 9.64 | exchanges | |
| Number of Plasma Exchanges | Historic Control | 16.1 | Standard Deviation 8.93 | exchanges | |
| Time to Remission | Danazol, Plex, Steroids | 11.4 | Standard Deviation 5.05 | days | |
| Time to Remission | Historic Control | 11.0 | Standard Deviation 7.06 | days | |
| Length of Stay | Danazol, Plex, Steroids | 27.3 | Standard Deviation 17.7 | days | |
| Length of Stay | Historic Control | 24.9 | Standard Deviation 13.1 | days | |
| Number of Participants With Complete and Continuous Response Rate | Danazol, Plex, Steroids | Complete Response Rate | 9 | Participants | |
| Number of Participants With Complete and Continuous Response Rate | Historic Control | Complete Response Rate | 17 | Participants | |
| Number of Participants With Complete and Continuous Response Rate | Danazol, Plex, Steroids | Continuous Response Rate | 8 | Participants | |
| Number of Participants With Complete and Continuous Response Rate | Historic Control | Continuous Response Rate | 16 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Danazol, Plex, Steroids | 9 | |
| Overall Study | STARTED | Historic Control | 20 | |
| Overall Study | COMPLETED | Danazol, Plex, Steroids | 8 | |
| Overall Study | COMPLETED | Historic Control | 20 | |
| Overall Study | NOT COMPLETED | Danazol, Plex, Steroids | 1 | |
| Overall Study | NOT COMPLETED | Historic Control | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | pulmonary edema | Respiratory, thoracic and mediastinal disorders | Danazol, Plex, Steroids | 1 | 9 | |
| serious | pulmonary edema | Respiratory, thoracic and mediastinal disorders | Historic Control | 0 | 0 | |
| serious | hypotension | Vascular disorders | Danazol, Plex, Steroids | 1 | 9 | |
| serious | hypotension | Vascular disorders | Historic Control | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Danazol, Plex, Steroids | 1 | 9 |
| Total, all-cause mortality | Historic Control | 0 | 0 |
| Total, other adverse events | Danazol, Plex, Steroids | 0 | 9 |
| Total, other adverse events | Historic Control | 0 | 0 |
| Total, serious adverse events | Danazol, Plex, Steroids | 2 | 9 |
| Total, serious adverse events | Historic Control | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Danazol, Plex, Steroids vs Historic Control: Number of Participants With Relapses |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00953771
GET https://conductscience.org/api/trials/v1/NCT00953771/registered