Trial · NCT01380743
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 108
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | Cohort 1, Duvoglustat 50 mg + rhGAA | 0 | Participants | ||
| Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | Cohort 2, Duvoglustat 100 mg + rhGAA | 0 | Participants | ||
| Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | Cohort 3, Duvoglustat 250 mg + rhGAA | 0 | Participants | ||
| Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | Cohort 4, Duvoglustat 600 mg + rhGAA | 1 | Participants | ||
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 1, Duvoglustat 50 mg + rhGAA | Total GAA, Period 1 | 17269 | Geometric Coefficient of Variation 25.6 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 2, Duvoglustat 100 mg + rhGAA | Total GAA, Period 1 | 22785 | Geometric Coefficient of Variation 18.1 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 3, Duvoglustat 250 mg + rhGAA | Total GAA, Period 1 | 18986 | Geometric Coefficient of Variation 19.5 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 4, Duvoglustat 600 mg + rhGAA | Total GAA, Period 1 | 18980 | Geometric Coefficient of Variation 34.6 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 1, Duvoglustat 50 mg + rhGAA | Total GAA, Period 2 | 20539 | Geometric Coefficient of Variation 21.2 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 2, Duvoglustat 100 mg + rhGAA | Total GAA, Period 2 | 28607 | Geometric Coefficient of Variation 14.1 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 3, Duvoglustat 250 mg + rhGAA | Total GAA, Period 2 | 22651 | Geometric Coefficient of Variation 9.0 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 4, Duvoglustat 600 mg + rhGAA | Total GAA, Period 2 | 22989 | Geometric Coefficient of Variation 36.4 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 1, Duvoglustat 50 mg + rhGAA | rhGAA, Period 1 | 328660 | Geometric Coefficient of Variation 40.7 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 2, Duvoglustat 100 mg + rhGAA | rhGAA, Period 1 | 399622 | Geometric Coefficient of Variation 33.2 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 3, Duvoglustat 250 mg + rhGAA | rhGAA, Period 1 | 405543 | Geometric Coefficient of Variation 11.4 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 4, Duvoglustat 600 mg + rhGAA | rhGAA, Period 1 | 507294 | Geometric Coefficient of Variation 47.9 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 1, Duvoglustat 50 mg + rhGAA | rhGAA, Period 2 | 385475 | Geometric Coefficient of Variation 35.7 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 2, Duvoglustat 100 mg + rhGAA | rhGAA, Period 2 | 430738 | Geometric Coefficient of Variation 39.5 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 3, Duvoglustat 250 mg + rhGAA | rhGAA, Period 2 | 438795 | Geometric Coefficient of Variation 7.0 | nmol/mL/h |
| Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease | Cohort 4, Duvoglustat 600 mg + rhGAA | rhGAA, Period 2 | 637571 | Geometric Coefficient of Variation 48.8 | nmol/mL/h |
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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