Trial · NCT00838513
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With TMA Event-free Status | Through 26 weeks | The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Patients With Hematologic Normalization | Through 26 weeks | Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Patients With Complete TMA Response | Through 26 weeks | Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced. | Percentage of Participants | NUMBER |
| SECONDARY | TMA Intervention Rate | Through 26 weeks | A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population. | #events/patient/day | MEAN |
| SECONDARY | Platelet Count Change From Baseline to 26 Weeks | From Baseline to 26 Weeks | Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point. | 10^9 cells/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With Platelet Count Normalization | Through 26 Weeks | The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With TMA Event-free Status | Through End of Study, Median Exposure 156 Weeks | The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Hematologic Normalization | Through End of Study, Median Exposure 156 Weeks | Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Complete TMA Response | Through End of Study, Median Exposure 156 Weeks | Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced. | Percentage of Participants | NUMBER |
| SECONDARY | TMA Intervention Rate | Through End of Study, Median Exposure 156 Weeks | A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population. | #events/patient/day | MEAN |
| SECONDARY | Platelet Count Change From Baseline to 156 Weeks | From Baseline to 156 Weeks | Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point. | 10^9 cells/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With Platelet Count Normalization | Through End of Study, Median Exposure 156 Weeks | The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration | Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer. | PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. | micrograms/mil | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT00838513/outcomes