A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
20actual
Sites
4
Countries
Canada, United Kingdom, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-03-20 | actual | When the study began enrolling |
| Primary completion | 2020-08-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2018-10-02 | actual | When this record first appeared on the registry |
| Results posted | 2021-11-15 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Thalassemia
Intervention
- Drug: AG-348 — also filed as Mitapivat
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants Achieving a Hemoglobin Response (HR)
measured Up to 12 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-08-26 · 13.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2020-07-27 · 648 KB · SAP_001.pdf
Publications
- PMID 35964609 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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