Trial · NCT01244763
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number (%) of Participants With an Hb Response by Week 17 | Up to Week 17 | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| 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) | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| 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) | Baseline is defined as the mean of the last 3 available values predose. |
| 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) | Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive. |
| 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) | |
| 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) | Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks. |
| 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) | |
| 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) | Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| 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) | Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| 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) | |
| 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) | |
| 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]) | |
| 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) | The mean percentage of the scheduled weekly Hb values that were \<10.5, \>13, and \>14 g/dL during Weeks 13-17 and 18-25 is presented. |
| Secondary | Number (%) of Participants Requiring Rescue Therapy | Baseline up to Week 28 (end of study) | Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron |
| Secondary | Number (%) of Participants Requiring Therapeutic Phlebotomy | Baseline up to Week 28 (end of study) | |
| Secondary | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | Baseline up to Week 28 (end of study) | |
| 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) | Dose changes include dose reductions, dose increases, and dose holds. |
| 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) | |
| 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) | |
| 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) | Baseline was defined as the mean of the last 3 available values predose. |
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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