Trial · NCT02228460
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Week 26 in Skin Globotriaosylceramide (GL-3) Score in Superficial Skin Capillary Endothelium: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26 | Baseline, Week 26 | Analysis was performed on full analysis set (FAS) that included all participants who received at least 1 dose of study treatment. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline at Week 26 in Skin GL-3 Score in Superficial Skin Capillary Endothelium | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Plasma GL-3 Concentration at Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | mcg/mL | MEAN |
| SECONDARY | Change From Baseline in Plasma Lyso Globotriaosylceramide (Lyso-GL-3) Concentration at Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | ng/mL | MEAN |
| SECONDARY | Change From Baseline in Plasma Glucosylceramide (GL-1) Concentration at Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | mcg/mL | MEAN |
| SECONDARY | Change From Baseline at Week 26 in Skin GL-3 Score in Deep Vessels Endothelial Cells: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline at Week 26 in Skin GL-3 Score in Deep Vessels Smooth Muscle Cells: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline at Week 26 in Skin GL-3 Score in Perineurium Cells: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Urine Globotriaosylceramide (GL-3) Concentration at Week 26 | Baseline, Week 26 | Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26. | mg/mmol Cr | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Baseline up to 212 days | Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Maximum Plasma Drug Concentration (Cmax) of GZ/SAR402671 | Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose) | Analysis was performed on PK population which included all participants for whom the primary PK data were considered sufficient and interpretable. Here, 'number analyzed' = participants with available data at specified time-point. | ng/mL | MEAN |
| SECONDARY | PK: Plasma Trough Concentration (Ctrough) of GZ/SAR402671 | Predose on Days 14, 28, 56, 84, 126, and 182 | Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point. | ng/mL | MEAN |
| SECONDARY | PK: Time to Reach Maximum Plasma Drug Concentration (Tmax) of GZ/SAR402671 | Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose) | Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point. | hours | MEDIAN |
| SECONDARY | PK: Area Under Plasma Concentration Versus Time Curve From 0 to 24 Hours (AUC0-24) of GZ/SAR402671 | Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose) | Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point. | ng*hour/mL | MEAN |
| SECONDARY | PK: Terminal Half-life (t1/2z) of GZ/SAR402671 | Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose) | Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point. | hours | MEAN |
| SECONDARY | PK: Apparent Total Body Clearance of GZ/SAR402671 at Steady State (CLss/F) | Predose and 1, 2, 4, 8, and 24 hours post-dose on Day 182 | Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | mL/hour | MEAN |
| SECONDARY | PK: Apparent Volume of Distribution of GZ/SAR402671 (Vss/F) at Steady State | Predose and 1, 2, 4, 8, and 24 hours post-dose on Day 182 | Since the percent extrapolation of AUC for all participants was \>30%, AUC could not be determined and hence, Vss/F could not be calculated. | ||
| SECONDARY | PK: Cumulated Amount of GZ/SAR402671 Excreted in Urine From 0 to 24 Hours (Ae0-24) | 0-24 hours on Day 182 | Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | mcg | MEAN |
| SECONDARY | PK: Percentage of Dose of GZ/SAR402671 Excreted in Urine From 0 to 24 Hours (fe0-24) | 0-24 hours on Day 182 | Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | percentage of dose | MEAN |
| SECONDARY | PK: Renal Clearance (CLR) of GZ/SAR402671 From 0 to 24 Hours | 0-24 hours on Day 182 | Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | mL/hour | 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.
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