Trial · NCT01146574
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Observed Maximum Concentration (Cmax) | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | ug/mL | MEAN |
| PRIMARY | Time to Maximum Concentration (Tmax) | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Days | MEDIAN |
| PRIMARY | Area Under Curve (AUC)-28 Days | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | ug·day/mL | MEAN |
| PRIMARY | AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity | From first dose up to Day 28 | Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | ug·day/mL | MEAN |
| PRIMARY | Apparent Total Clearance (CL/F) | From first dose up to Day 28 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | L/day | MEAN |
| PRIMARY | Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | From first dose up to Day 28 | Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | mL/kg | MEAN |
| PRIMARY | Terminal Half-Life (t1/2,z) | Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113 | Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered. | Day | MEAN |
| SECONDARY | The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | From first dose up to 115 days post last dose | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hemoglobin > 12g/dL | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Blood Pressure Changes From Baseline | From pre-dose up to the final visit 112 days after last dose (up to 225 days) | Safety population- all randomized participant who received at least 1 dose of sotatercept and had evaluable safety data | mmHg | MEAN |
| SECONDARY | Changes in Follicle Stimulating Hormone (FSH) | Day 1 (baseline), Day 15, Day 29, and Day 113 | All randomized participants in Part 1 | IU/L | MEAN |
| SECONDARY | Number of Participants With Hemoglobin > 10g/dL | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 | All randomized participants in Part 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 | All randomized participants in Part 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL | Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309 | All randomized participants in Part 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Time to Rescue Therapy | From first dose up to blood transfusion or ESA therapy, up to approximately 209 days | Participants in Part 2 who received rescue therapy | Days | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Values | From first dose up to Day 225 | All randomized participants in Part 2 | g/L | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01146574/outcomes