Trial · NCT04000165
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number Participants With Most Common Reported Drug Related Adverse Events | 14 weeks | To assess the clinical safety and tolerability of multiple escalating doses of AG-348, an allosteric activator of the enzyme pyruvate kinase, in subjects with stable sickle cell disease (SCD). Safety and tolerability were assessed by frequency and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Primary | Number Participants With Serious Adverse Events That Were Possibly Drug-related Serious Adverse Events | 14 weeks | To assess the clinical safety and tolerability of multiple escalating doses of AG-348, an allosteric activator of the enzyme pyruvate kinase, in subjects with stable sickle cell disease (SCD). Safety and tolerability were assessed by frequency and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Primary | Number Participants With Increase of ≥ 1 g/dL in Hemoglobin | 14 weeks | To assess the clinical safety and tolerability of multiple escalating doses of AG-348, an allosteric activator of the enzyme pyruvate kinase, in subjects with stable sickle cell disease (SCD). Safety and tolerability were assessed by defined as a ≥ 1 g/dL increase in hemoglobin at any dose level compared to baseline. |
| Secondary | Change in Hemoglobin at Each Dose Level of AG-348 | 14 weeks | To assess change in hemoglobin in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Change in Lactic Acid Dehydrogenase (LDH) at Each Dose Level of AG-348 | 14 weeks | To assess change in lactic acid dehydrogenase (LDH) in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Change in Total Bilirubin at Each Dose Level of AG-348 | 14 weeks | To assess change in total bilirubin in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Change in Absolute Reticulocyte Count at Each Dose Level of AG-348 | 14 weeks | To assess change in absolute reticulocyte count in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Change in Aspartate Aminotransferase (AST) at Each Dose Level of AG-348 | 14 weeks | To assess change in aspartate aminotransferase (AST) in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Change in Mean Corpuscular Volume (MCV) at Each Dose Level of AG-348 | 14 weeks | To assess change in mean corpuscular volume (MCV) in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Change in Fetal Hemoglobin at Each Dose Level of AG-348 | 14 weeks | To assess the change in fetal hemoglobin (HbF) in stable sickle cell disease participants at each dose level of AG-348 |
| Secondary | Percent Change From Baseline of 2,3-DPG at Each Dose Level of AG-348 | 14 weeks | To understand the mechanisms of action of AG- 348 on the glycolytic pathway in sickle cell disease through laboratory studies of specific pharmacodynamics of 2,3-DPG at each dose level of AG-348. |
| Secondary | Percent Change From Baseline of Adenosine Triphosphate (ATP) at Each Dose Level of AG-348 | 14 weeks | To understand the mechanisms of action of AG- 348 on the glycolytic pathway in sickle cell disease through laboratory studies of specific pharmacodynamics of adenosine triphosphate (ATP) at each dose level of AG-348. |
| Secondary | Percent Change From Baseline in Oxygen Binding p50 Value at Each Dose Level of AG-348 | 14 weeks | Measure percent change from baseline in oxygen binding p50 value at each dose level of AG-348 |
| Secondary | Percent Change in Time (Mins) at Which 50% of Red Blood Cells Are Sickled (t50) Value at Each Dose Level of AG-348 | 14 weeks | Measure percent change in Time (mins) at which 50% of red blood cells are sickled (t50) Value at Each Dose Level of AG-348 |
| Secondary | Percent Change of PK-R at Each Dose Level of AG-348 | 14 weeks | To understand the mechanisms of action of AG- 348 on the glycolytic pathway in sickle cell disease through laboratory studies of specific pharmacodynamics of PK-R at each dose level of AG-348. |
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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