Trial Outcomes & Findings for Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP) (NCT NCT00799773)
NCT ID: NCT00799773
Last Updated: 2013-07-22
Results Overview
TERMINATED
PHASE3
3 participants
Measured at Day 52
2013-07-22
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
|
Standard of Care
Participants will receive plasma exchange and corticosteroids.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)
Baseline characteristics by cohort
| Measure |
Rituximab
n=2 Participants
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
|
Standard of Care
n=1 Participants
Participants will receive plasma exchange and corticosteroids.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
43.5 years
STANDARD_DEVIATION 26.2 • n=5 Participants
|
24 years
n=7 Participants
|
37 years
STANDARD_DEVIATION 22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 52Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 36Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Days 52 and 82Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Days 52 and 82Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 36Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 36Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Day 52Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 36Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 36Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 6Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 12Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 12Population: 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.
Outcome measures
Outcome data not reported
Adverse Events
Rituximab
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan F. Assmann, PhD
New England Research Institutes, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place