Trial · NCT02489344
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of investigational medicinal product (IMP) during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Urinalysis | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | From baseline of ACT13739 study up to 37 months post-ACT13739 baseline | Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Plasma Globotriaosylceramide (GL-3) Concentration at Weeks 26, 52, 104, and 156 | Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | micrograms per milliliter (mcg/mL) | MEAN |
| SECONDARY | Change From Baseline in Plasma Lyso Globotriaosylceramide (Lyso GL-3) Concentration at Weeks 26, 52, 104, and 156 | Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | nanograms per mL (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Plasma Glucosylceramide (GL-1) Concentration At Weeks 26, 52, 104, and 156 | Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | mcg/mL | MEAN |
| SECONDARY | Change From Baseline in Plasma Monosialodihexosylganglioside (GM3) Concentration At Weeks 26, 52, 104, and 156 | Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | mcg/mL | MEAN |
| SECONDARY | Change From Baseline in Urine GL-3 Concentration At Weeks 26, 52, 104, and 156 | Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | mg/mmol creatinine (Cr) | MEAN |
| SECONDARY | Change From Baseline in High Sensitivity Cardiac Troponin T At Weeks 26, 52, 104, and 156 | Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | mcg/L | MEAN |
| SECONDARY | Change From Baseline in Podocyturia Counts (Per Milligram of Creatinine) At Weeks 12, 26, and 156 | Baseline of ACT13739 study and Weeks 12, 26, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | Count of podocytes/mg Cr | MEAN |
| SECONDARY | Summary of Shifts From Baseline in Skin GL-3 Score in Superficial Capillary Endothelial Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score | Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Shifts From Baseline in Skin GL-3 Score in Deep Vessels Endothelial Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score | Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Shifts From Baseline in Skin GL-3 Score in Deep Vessels Smooth Muscle Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score | Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Shifts From Baseline in Skin GL-3 Score in Perineurium Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score | Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline | Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, 'number analyzed' = participants with available data for each specified category. | Participants | COUNT_OF_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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GET https://conductscience.org/api/trials/v1/NCT02489344/outcomes