We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799773
Recruitment Status : Terminated (Low enrollment rate)
First Posted : December 1, 2008
Results First Posted : July 22, 2013
Last Update Posted : July 22, 2013
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Genentech, Inc.
Information provided by (Responsible Party):
HealthCore-NERI

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thrombotic Thrombocytopenic Purpura
Interventions Drug: Rituximab
Procedure: Plasma exchange
Drug: Corticosteroids
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description Participants will receive rituximab in addition to plasma exchange and corticosteroids. Participants will receive plasma exchange and corticosteroids.
Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Rituximab Standard of Care Total
Hide Arm/Group Description Participants will receive rituximab in addition to plasma exchange and corticosteroids. Participants will receive plasma exchange and corticosteroids. Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
43.5  (26.2) 24 37  (22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids
Hide Description [Not Specified]
Time Frame Measured at Day 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Use of Non-study Treatment
Hide Description [Not Specified]
Time Frame Measured at Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab
Hide Description [Not Specified]
Time Frame Measured at Days 52 and 82
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Relationship Between Clinical and Laboratory Data and Response to Treatment
Hide Description [Not Specified]
Time Frame Measured at Days 52 and 82
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response
Hide Description [Not Specified]
Time Frame Measured at Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title All Cause Mortality
Hide Description [Not Specified]
Time Frame Measured at Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Treatment-related Complications
Hide Description [Not Specified]
Time Frame Measured at Day 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Measured at Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13
Hide Description [Not Specified]
Time Frame Measured at Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Effect of Plasma Exchange on Rituximab Levels
Hide Description [Not Specified]
Time Frame Measured at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)
Hide Description [Not Specified]
Time Frame Measured at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not
Hide Description [Not Specified]
Time Frame Measured at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description:
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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, to protect subject confidentiality adverse events, though collected, are not being reported for this study.
 
Arm/Group Title Rituximab Standard of Care
Hide Arm/Group Description Participants will receive rituximab in addition to plasma exchange and corticosteroids. Participants will receive plasma exchange and corticosteroids.
All-Cause Mortality
Rituximab Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Rituximab Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
One treatment arm had only one subject, so to protect patient confidentiality, results are not being entered.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan F. Assmann, PhD
Organization: New England Research Institutes, Inc.
Phone: 617-923-7747 ext 548
EMail: sassmann@neriscience.com
Layout table for additonal information
Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT00799773    
Other Study ID Numbers: 558
U01HL072268 ( U.S. NIH Grant/Contract )
HL072268
HL072033
HL072291
HL072196
HL072248
HL072191
HL072305
HL072028
HL072072
HL072355
HL072283
HL072346
HL072331
HL072290
First Submitted: November 26, 2008
First Posted: December 1, 2008
Results First Submitted: May 7, 2013
Results First Posted: July 22, 2013
Last Update Posted: July 22, 2013