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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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