Trial · NCT03692052
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Hemoglobin Response (HR) | Up to 12 weeks | HR was defined as a ≥1.0 gram per deciliter (g/dL) increase in Hb concentration from Baseline at 1 or more assessments between Week 4 and Week 12 (inclusive). A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug. |
| Secondary | Average Change From Baseline in Hb Concentrations From Week 12 to Week 24 | Baseline, Week 12 to Week 24 | A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug. |
| Secondary | Percentage of Participants Achieving a Sustained Hb Response (sHR) | Week 12 to Week 24 | sHR was defined as achieving HR and achieving a ≥1.0 g/deciliter (dL) increase in Hb concentration at 2 or more evaluable Hb assessments out of the 4 scheduled assessments between the Week 12 visit and Week 24 visit. |
| Secondary | Percentage of Participants Achieving a Delayed Hb Response | Week 12 to Week 24 | Delayed Hb response was defined as not achieving HR and achieving a ≥1.0 g/dL increase in Hb concentration at 1 or more Hb assessments after Week 12. |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
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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