Trial · NCT01244763
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number (%) of Participants With an Hb Response by Week 17 | Up to Week 17 | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | g/dL | MEAN |
| SECONDARY | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | days | MEDIAN |
| SECONDARY | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | days | MEDIAN |
| SECONDARY | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. | mg/kg/week | MEDIAN |
| SECONDARY | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. | g/dL | MEAN |
| SECONDARY | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment]) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | g/dL | MEAN |
| SECONDARY | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. LOCF method was used to impute missing values. | percentage of Hb values | MEAN |
| SECONDARY | Number (%) of Participants Requiring Rescue Therapy | Baseline up to Week 28 (end of study) | Safety Population included all participants who received any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants Requiring Therapeutic Phlebotomy | Baseline up to Week 28 (end of study) | Safety Population included all participants who received any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | Baseline up to Week 28 (end of study) | Safety Population included all participants who received any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only) | Safety Population included all participants who received any dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | mg/kg | MEAN |
| SECONDARY | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment) | Safety Population included all participants who received any dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. | mg/kg | MEAN |
| SECONDARY | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment) | EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. Last-observation-carried-forward (LOCF) method was used to impute missing values. | g/dL | 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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