At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
AG-348drug
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.
A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency
In Brief
A Phase 2 clinical trial evaluating AG-348 for Pyruvate Kinase Deficiency. Completed, enrolled 52 participants across 13 sites in 6 countries.
Detailed Summary
Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of different dose levels of AG-348 (mitapivat) in participants with PK deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPyruvate Kinase Deficiency
CountriesCanada, France, Italy, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionMay 2017
Study CompletionApr 2025
TodayJul 2026
First PostedJun 22, 2015
Enrollment StartJun 26, 2015
Primary CompletionMay 8, 2017
Study CompletionApr 2, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.0 years ago
Interventions
AG-348drug
Tablets