Trial · NCT00713193
Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)
NCT00713193, Phase 3, Completed, Ohio State University; results first posted 2023-04-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP). Trials, record NCT00713193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00713193
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)
- NCT number
- NCT00713193
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Interventions
- Cyclosporine, Prednisone
- First posted
- 2008-07-11
- Last updated
- 2023-05-03
- Results first posted
- 2023-04-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm | From the start of treatment until 30 days after discharge from the last PEX procedure | Number of Participants with Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm |
| Secondary | Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm. | Time to starting treatment until 6 months after the last PEX procedure | Days to achieve a clinical response, defined as a normal platelet count (\>150 x 109/L), normal LDH, and no new end organ injury. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm | From the start of treatment until 30 days after discharge from the last PEX procedure | participants | NUMBER | |
| SECONDARY | Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm. | Time to starting treatment until 6 months after the last PEX procedure | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm | CSA Arm | 3 | participants | ||
| Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm | Prednisone Arm | 1 | participants | ||
| Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm. | CSA Arm | 5 | Full Range 4 to 19 | Days | |
| Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm. | Prednisone Arm | 5 | Full Range 4 to 8 | Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CSA Arm | 12 | |
| Overall Study | STARTED | Prednisone Arm | 14 | |
| Overall Study | COMPLETED | CSA Arm | 12 | |
| Overall Study | COMPLETED | Prednisone Arm | 14 | |
| Overall Study | NOT COMPLETED | CSA Arm | 0 | |
| Overall Study | NOT COMPLETED | Prednisone Arm | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CSA Arm | 1 | 12 |
| Total, all-cause mortality | Prednisone Arm | 1 | 14 |
| Total, other adverse events | CSA Arm | 0 | 12 |
| Total, other adverse events | Prednisone Arm | 0 | 14 |
| Total, serious adverse events | CSA Arm | 0 | 12 |
| Total, serious adverse events | Prednisone Arm | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29296854 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003932 | Ph 3 of Cyclosporine or Corticosteroids Adjunct to Plasma Exhcange in Tx of TTP | CATALAND, SPERO R. | OHIO STATE UNIVERSITY | FOOD AND DRUG ADMINISTRATION | 2011 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CSA Arm vs Prednisone Arm: Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm | Trial comparisons |
| CSA Arm vs Prednisone Arm: deaths from any cause | Trial comparisons |
| CSA Arm vs Prednisone Arm: serious adverse events | 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/NCT00713193
GET https://conductscience.org/api/trials/v1/NCT00713193/registered