Trial · NCT01999582
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) | Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | day*ng/mL | MEAN |
| PRIMARY | Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d) | Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | day*ng/mL | MEAN |
| PRIMARY | Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d) | Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | ng/mL | MEAN |
| PRIMARY | Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses | Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | ng/mL | MEAN |
| PRIMARY | Time to Reach Maximum Observed Serum Concentration (Tmax) | Doses 1-2: pre- and postdose at 5 min (IV only) 4 hrs, 3, and 7 days after each dose; Doses 3-7: pre-, and postdose at 5 min after IV injection after each dose; Final dose: pre- and postdose at 5 min (IV only), 4 hrs, 3, 7, 14, 28, 56, 84, and 112 days | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | days | MEDIAN |
| PRIMARY | Estimate of Terminal Elimination Half-Life in Serum at Final Dose Only (t1/2) | Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose. | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | days | MEAN |
| PRIMARY | Lambda (ʎz): Apparent Terminal Rate Constant (at Final Dose Only) | Predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14, 28, 56, 84, and 112 days after the final dose | Pharmacokinetic population-all treated participants with at least one non-missing plasma concentration data for this endpoint | 1/day | MEAN |
| SECONDARY | Percentage of Participants With Mean Hemoglobin ≥ 100 g/L to ≤ 120 g/L Without Rescue Medication | Visit 14 to Visit 17 (days 99 to 113) | All randomized participants | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (All Participants Regardless of Rescue) | Baseline and Visit 14 to Visit 17 (days 99 to 113) | All randomized participants who received at least one dose of treatment. | g/L | MEAN |
| SECONDARY | Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (Participants Not Rescued Prior to Day 115) | Baseline and Visit 14 to Visit 17 (days 99 to 113) | All randomized participants who received at least one dose of treatment and were not rescued prior to Day 115. | g/L | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From date of first dose of investigational product to 112 days after the last dose or until the last study visit, whichever period was longer. The maximum duration for any IV or SC dose was 114 days. Up to approximately 226 days. | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01999582/outcomes