Trial · NCT01554514

Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

NCT01554514, Phase 2, Completed, Washington University School of Medicine; results first posted 2021-08-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura. Trials, record NCT01554514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01554514

On this page

Trial

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

Title: Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura
NCT number: NCT01554514
Status: Completed
Phases: Phase 2
Enrollment: 19 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Thrombotic Thrombocytopenic Purpura
Interventions: rituximab
First posted: 2012-03-15
Last updated: 2021-08-17
Results first posted: 2021-08-13

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP	60 days	Exacerbation is recurring TTP ≤30 days after a Treatment Response (normal platelet count for 2 days) and discontinuation of plasma exchange. Refractory TTP is failure to achieve a Treatment Response by day 28, or failure to achieve a Durable Treatment Response (lasting at least 30 days) by day 60.
Secondary	Incidence of Durable Treatment Response	60 days	Treatment Response is 2 consecutive days with platelet count ≥150, 000/µL Durable Treatment Response is a Treatment Response that persists for ≥30 days after discontinuation of plasma exchange and includes those with exacerbations
Secondary	Number of Days to Durable Treatment Response	60 days	Median time to treatment response
Secondary	Incidence of Relapse	Between 30 days and 2 years	Relapse is recurring TTP \>30 days after Treatment Response
Secondary	Months to Relapse	2 years	Mean months to relapse
Secondary	Incidence of Death	2 years	Incidence of death will be assessed at 4 weeks, 1 year and 2 years
Secondary	Treatment-related Adverse Events	2 years	Incidence, type and severity of treatment-related adverse events will be assessed. Patient reports, lab values, and physical exam were used to identify treatment-related adverse events.

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	Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP	60 days	Completed adjuvant riituximab therapy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Durable Treatment Response	60 days	Completed adjuvant rituximab therapy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Days to Durable Treatment Response	60 days	Completed adjuvant rituximab therapy	days	MEDIAN
SECONDARY	Incidence of Relapse	Between 30 days and 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Months to Relapse	2 years	Completed adjuvant rituximab	months	MEAN
SECONDARY	Incidence of Death	2 years	Completed adjuvant rituximab	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment-related Adverse Events	2 years	Completed adjuvant rituximab therapy	treatment-related adverse events	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP	Low Dose Rituximab	Number with exacerbation	2		Participants
Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP	Low Dose Rituximab	Number with refractory TTP	0		Participants
Incidence of Durable Treatment Response	Low Dose Rituximab		17		Participants
Number of Days to Durable Treatment Response	Low Dose Rituximab		5	Full Range 1 to 18	days
Incidence of Relapse	Low Dose Rituximab		5		Participants
Months to Relapse	Low Dose Rituximab		17.3	Full Range 11 to 22	months
Incidence of Death	Low Dose Rituximab		1		Participants
Treatment-related Adverse Events	Low Dose Rituximab		13		treatment-related adverse events

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose Rituximab	19
Overall Study	COMPLETED	Low Dose Rituximab	17
Overall Study	NOT COMPLETED	Low Dose Rituximab	2

Source ClinicalTrials.gov

Adverse events83

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
other	rhinorrhea	Respiratory, thoracic and mediastinal disorders	Low Dose Rituximab	1	17	1
other	fatigue	General disorders	Low Dose Rituximab	3	17	3
other	decreased appetite	Metabolism and nutrition disorders	Low Dose Rituximab	1	17	1
other	cough	Respiratory, thoracic and mediastinal disorders	Low Dose Rituximab	4	17	4
other	dizziness	Nervous system disorders	Low Dose Rituximab	2	17	3
other	headache	Nervous system disorders	Low Dose Rituximab	4	17	5
other	hematuria	Renal and urinary disorders	Low Dose Rituximab	1	17	1
other	anemia	Blood and lymphatic system disorders	Low Dose Rituximab	7	17	12
other	thrombocytopenia	Investigations	Low Dose Rituximab	4	17	6
other	cervical lymphadenopathy	Blood and lymphatic system disorders	Low Dose Rituximab	1	17	1

1 to 10 of 83Source ClinicalTrials.gov

See all 83 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Dose Rituximab	1	17
Total, other adverse events	Low Dose Rituximab	17	19
Total, serious adverse events	Low Dose Rituximab	10	17

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12353309	RESULT	PubMed
15389904	RESULT	PubMed
20058208	RESULT	PubMed
21926591	BACKGROUND	PubMed
23279219	RESULT	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
U54HL112303	Proteases in the Pathogenesis and Treatment of Thrombosis	SADLER, J EVAN	WASHINGTON UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2012 to 2016

Source NIH RePORTER

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/NCT01554514

GET https://conductscience.org/api/trials/v1/NCT01554514/events?page=2

API reference For AI assistants