Trial · NCT03692052
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Hemoglobin Response (HR) | Up to 12 weeks | FAS included all participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Average Change From Baseline in Hb Concentrations From Week 12 to Week 24 | Baseline, Week 12 to Week 24 | FAS included all participants who received at least 1 dose of study treatment. Number analyzed is the number of participants with data available for analysis at the given time point. | grams per liter (g/L) | MEAN |
| SECONDARY | Percentage of Participants Achieving a Sustained Hb Response (sHR) | Week 12 to Week 24 | FAS included all participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Delayed Hb Response | Week 12 to Week 24 | FAS included all participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hb Concentration Over the Duration of the Extension Period | Baseline up to approximately 10.5 years | |||
| SECONDARY | Time to First ≥1.0 g/dL Increase in Hb Concentration | Up to Week 24 | Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment. Data is reported for the responders. | weeks | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Count | Up to approximately 10.5 years | |||
| SECONDARY | Change From Baseline in Bilirubin | Up to approximately 10.5 years | |||
| SECONDARY | Change From Baseline in Lactate Dehydrogenase (LDH) | Up to approximately 10.5 years | |||
| SECONDARY | Change From Baseline in Haptoglobin | Up to approximately 10.5 years | |||
| SECONDARY | Change From Baseline in Nucleated Red Blood Cells (NRBCs) | Up to approximately 10.5 years | |||
| SECONDARY | Change From Baseline in Erythropoietin (EPO) | Up to approximately 10.5 years | |||
| SECONDARY | Change From Baseline in Soluble Transferrin Receptor | Up to approximately 10.5 years | |||
| SECONDARY | Drug Concentrations Over Time for AG-348 | Predose (60 minutes) and 0.00 hour, 0.50 hour, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The Pharmacokinetic (PK) Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | AUC0-8h: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours of AG-348 | Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The PK Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | nanograms*hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of AG-348 | Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The PK Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration of AG-348 | Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The PK Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) | Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The PK Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | hours | MEDIAN |
| SECONDARY | Tlast: Time of the Last Quantifiable Concentration of AG-348 | Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The PK Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | hours | MEDIAN |
| SECONDARY | Ctrough: Observed Plasma Concentration at the End of a Dosing Interval of AG-348 | Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12 | The PK Analysis Set included all participants who were enrolled and received a dose of study medication (AG-348), with at least one non-zero plasma concentration of AG-348 at Day 1 or Week 12 (or the Unscheduled Visit where intensive PK samples were assessed). Number analyzed is the number of participants with data available for analysis at the given time point. | ng/mL | GEOMETRIC_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/NCT03692052/outcomes