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Trial · NCT00799773

Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)

NCT00799773, Phase 3, Terminated, Carelon Research; results first posted 2013-07-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP). Trials, record NCT00799773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00799773

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)
NCT number
NCT00799773
Status
Terminated
Phases
Phase 3
Enrollment
3 participants, actual
Lead sponsor
Carelon Research
Conditions
Thrombotic Thrombocytopenic Purpura
Interventions
Rituximab, Plasma exchange, Corticosteroids
First posted
2008-12-01
Last updated
2013-07-22
Results first posted
2013-07-22
Limitations and caveats
One treatment arm had only one subject, so to protect patient confidentiality, results are not being entered.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRole of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and CorticosteroidsMeasured at Day 52
SecondaryUse of Non-study TreatmentMeasured at Month 36
SecondaryWhether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving RituximabMeasured at Days 52 and 82
SecondaryRelationship Between Clinical and Laboratory Data and Response to TreatmentMeasured at Days 52 and 82
SecondaryIncidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment ResponseMeasured at Month 36
SecondaryAll Cause MortalityMeasured at Month 36
SecondaryTreatment-related ComplicationsMeasured at Day 52
Secondary
Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate
Measured at Month 36
SecondaryRituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13Measured at Month 36
SecondaryEffect of Plasma Exchange on Rituximab LevelsMeasured at Month 6

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYRole of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and CorticosteroidsMeasured at Day 52
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYUse of Non-study TreatmentMeasured at Month 36
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYWhether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving RituximabMeasured at Days 52 and 82
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYRelationship Between Clinical and Laboratory Data and Response to TreatmentMeasured at Days 52 and 82
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYIncidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment ResponseMeasured at Month 36
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYAll Cause MortalityMeasured at Month 36
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYTreatment-related ComplicationsMeasured at Day 52
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARY
Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate
Measured at Month 36
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYRituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13Measured at Month 36
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.
SECONDARYEffect of Plasma Exchange on Rituximab LevelsMeasured at Month 6
The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDRituximab2
Overall StudySTARTEDStandard of Care1
Overall StudyCOMPLETEDRituximab2
Overall StudyCOMPLETEDStandard of Care1
Overall StudyNOT COMPLETEDRituximab0
Overall StudyNOT COMPLETEDStandard of Care0

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.

TotalGroupAffectedAt risk
Total, all-cause mortalityRituximab
Total, all-cause mortalityStandard of Care
Total, other adverse eventsRituximab00
Total, other adverse eventsStandard of Care00
Total, serious adverse eventsRituximab00
Total, serious adverse eventsStandard of Care00

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U01HL072268Transfusion Medicine/Hemostasis Clinical Trials Network-Data Coordinating CenterASSMANN, SUSAN FERANEW ENGLAND RESEARCH INSTITUTES, INC.NATIONAL HEART, LUNG, AND BLOOD INSTITUTE2002 to 2012

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT00799773

GET https://conductscience.org/api/trials/v1/NCT00799773/registered