Trial · NCT02850406
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 54
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Maximum Concentration (Cmax) of Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | |
| Primary | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | AUC0-last was calculated using the linear/log trapezoid rule. |
| Primary | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96,168 and 336 hours post-dose | AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration for whole blood and lambdaz=elimination rate constant. |
| Primary | Part B: Change From Baseline to Week 24 in Hemoglobin Level | Baseline, Week 24 | |
| Primary | Part C: Change From Baseline to Week 48 in Cerebral Blood Flow | Baseline, Week 48 | Cerebral blood flow was measured using transcranial Doppler (TCD) sonography. Change from baseline in cerebral blood flow as measured by the time-averaged mean of the maximum (TAMM) TCD velocity is reported. |
| Primary | Part D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From start of study treatment up to 28 days after study treatment discontinuation (Up to 52 weeks) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. TEAE was defined as an AE that emerged on or after initiation of study drug (having been absent pre-treatment), or an AE that existed pre-treatment and worsened on treatment (relative to the pre-treatment state) through 28 days after study drug discontinuation. An SAE was any AE that resulted in any of the following outcomes: death, life threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, other important medical events. AEs were classified as SCD-related and non-SCD related. |
| Secondary | Part A: Maximum Concentration (Cmax) of Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | |
| Secondary | Part A: Maximum Concentration (Cmax) of Voxelotor in Red Blood Cells (RBC) | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | |
| Secondary | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | AUC0-last was calculated using the linear/log trapezoid rule. |
| Secondary | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | AUC0-last was calculated using the linear/log trapezoid rule. |
| Secondary | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration for plasma and lambdaz is the elimination rate constant. |
| Secondary | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant. |
| Secondary | Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | |
| Secondary | Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | |
| Secondary | Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | |
| Secondary | Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | T1/2 was the time measured for the drug concentration to decrease by one half. |
| Secondary | Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | T1/2 was the time measured for the drug concentration to decrease by one half. |
| Secondary | Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | T1/2 was the time measured for the drug concentration to decrease by one half. |
| Secondary | Part A: Percentage Hemoglobin (Hb) Occupancy | 15 days | Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula: (\[Concentration of voxelotor in whole blood- {1-hematocrit}\]\*\[Concentration of voxelotor in plasma/hematocrit\])/5000\*100. |
| Secondary | Part B: Percentage of Days With SCD Symptom Exacerbation During the First 24 Weeks of Treatment | From Day 1 up to 24 weeks | SCD symptoms were measured using the Patient Reported Outcome (PRO), Sickle Cell Disease Severity Measure (SCDSM) which was a self-administered 9-item questionnaire of SCD core symptoms including pain severity, frequency, and type, as well as fatigue and mental acuity, on a 4-point response scale that was completed daily using a handheld electronic device by the 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
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