At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 90 enrolled
Drug / intervention
Mitapivatdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects With Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies
In Brief
A Phase 3 clinical trial evaluating Mitapivat for Pyruvate Kinase Deficiency. Completed, enrolled 90 participants across 42 sites in 16 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPyruvate Kinase Deficiency
CountriesBrazil, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Netherlands, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionJul 2024
TodayJul 2026
First PostedFeb 26, 2019
Enrollment StartMar 21, 2019
Primary CompletionJul 3, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.4 years ago
Interventions
Mitapivatdrug
Tablets