This is an open-label, multicenter, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with mitapivat in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Timeframe: Up to 197 weeks
All Cohorts: Number of Participants With TEAEs Leading to Dose Reduction, Treatment Interruption and Treatment Discontinuation
Timeframe: Up to 197 weeks
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as Grade Greater Than or Equal to (≥)3 TEAEs
Timeframe: Up to 197 weeks
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Vital Signs Measurements and Physical Examinations Reported as TEAEs
Timeframe: Up to 197 weeks
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Bone Mineral Density (BMD)
Timeframe: Up to 192 weeks
All Cohorts: Change From Baseline in Adjusted Spine T-score
Timeframe: Baseline, Week 192
All Cohorts: Change From Baseline in Adjusted Spine Z-score
Timeframe: Baseline, Week 192
All Cohorts: Change From Baseline in Femoral Total T-score
Timeframe: Baseline, Week 192
All Cohorts: Change From Baseline in Femoral Total Z-score
Timeframe: Baseline, Week 192
All Cohorts: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters Reported as TEAEs
Timeframe: Up to 197 weeks