Trial · NCT03853798
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All Cohorts: Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3 | Up to 197 weeks | The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this outcome measure (OM) by Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All Cohorts: Number of Participants With TEAEs Leading to Dose Reduction, Treatment Interruption and Treatment Discontinuation | Up to 197 weeks | The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs | Up to 197 weeks | The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All Cohorts: Number of Participants With Clinically Significant Abnormalities in Vital Signs Measurements and Physical Examinations Reported as TEAEs | Up to 197 weeks | The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All Cohorts: Number of Participants With Clinically Significant Abnormalities in Bone Mineral Density (BMD) | Up to 192 weeks | The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All Cohorts: Change From Baseline in Adjusted Spine T-score | Baseline, Week 192 | The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | T-score | MEAN |
| PRIMARY | All Cohorts: Change From Baseline in Adjusted Spine Z-score | Baseline, Week 192 | The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Z-score | MEAN |
| PRIMARY | All Cohorts: Change From Baseline in Femoral Total T-score | Baseline, Week 192 | The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | T-score | MEAN |
| PRIMARY | All Cohorts: Change From Baseline in Femoral Total Z-score | Baseline, Week 192 | The safety analysis set included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Z- score | MEAN |
| PRIMARY | All Cohorts: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters Reported as TEAEs | Up to 197 weeks | The safety analysis set included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent studies AG348-C-006 (NCT03548220) and AG348-C-007 (NCT03559699), it was pre-specified in the SAP to report data for this OM by Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort 1: Percentage of Participants Who Achieved a Hemoglobin (Hb) Response | Baseline up to Week 24 | FAS included all participants who received at least 1 dose of study treatment. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent Study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 only based on FAS. | percentage of participants | NUMBER |
| SECONDARY | Cohort 1: Average Change From Baseline in Hb Concentration at Weeks 16, 20, and 24 | Baseline, Weeks 16, 20, and 24 | FAS included all participants who received at least 1 dose of study treatment. Overall number of participants analyzed indicates number of participants were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 only based on FAS. | grams per liter | MEAN |
| SECONDARY | Cohort 1: Area Under the Plasma Concentration-Time Curve From Time Zero to 8-hours Post-dose (AUC0-8) of Mitapivat | Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12 | PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS. | hour*nanograms per milliliter (hr*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Cohort 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Mitapivat | Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12 | PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Mitapivat | Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12 | PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat | Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12 | PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS. | hours | MEDIAN |
| SECONDARY | Cohort 1: Time of Last Quantifiable Concentration (Tlast) of Mitapivat | Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12 | PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS. | hours | MEDIAN |
| SECONDARY | Cohort 1: Plasma Concentration (Ctrough) at the End of a Dosing Interval of Mitapivat | Pre-dose, 0.5, 1, 2, 4, and 8 hours post-dose at Week 12 | PK analysis population: all participants who were enrolled \& received at least 1 dose of mitapivat with at least 1 nonzero plasma concentration of mitapivat at Week 12 visit. Overall number of participants analyzed: number of participants who received 50 mg BID mitapivat in Cohort 1 and were evaluable for this OM. As per planned analysis, data for this OM was reported by cohort and for Cohort 1 only based on FAS. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cohort 1: Exposure-response (E-R) Relationship Between Safety Parameters and Mitapivat Concentration and Relevant Mitapivat Pharmacokinetic Parameters | First dose to up to 24 weeks | After the dose optimization period, the 5 mg and 20 mg doses each had a single participant and the 50 mg dose had 36 participants. The exposure-relationship analysis planned cannot be performed with a single participant in multiple groups. | Percent probability | MEAN |
| SECONDARY | Cohorts 1 and 2: Change From Baseline in Hb Concentration | Baseline, Week 192 | FAS included all participants who received at least 1 dose of study treatment. Here, overall number of participants analyzed indicates the number of participants who were evaluable for this OM. Due to limited number of participants with optimal dose of 5 mg or 20 mg in antecedent study AG348-C-006 (NCT03548220), it was pre-specified in the SAP to report data for this OM by Cohort. As per planned analysis, data for this OM was reported for Cohort 1 and 2 only based on FAS. | grams per liter | 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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