Completed PHASE3 INTERVENTIONAL 4-arm NCT03548220

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

Sponsor: Agios Pharmaceuticals, Inc.

Conditions Anemia, Hemolytic Pyruvate Kinase Deficiency

Interventions AG-348 Placebo

Updated 30 times since 2018 Last updated: May 20, 2022 Started: Aug 9, 2018 Primary completion: Oct 9, 2020 Completion: Oct 9, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Anemia, Hemolytic and Pyruvate Kinase Deficiency and is currently completed. Agios Pharmaceuticals, Inc. leads this study, which shows 30 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

30 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jun 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Jun 2022 [monthly]

Completed PHASE3

▶ Show 25 earlier versions

Dec 2020 — Jan 2021 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Nov 2020 — Dec 2020 [monthly]

Active Not Recruiting PHASE3
Oct 2020 — Nov 2020 [monthly]

Active Not Recruiting PHASE3
Sep 2020 — Oct 2020 [monthly]

Active Not Recruiting PHASE3
Aug 2020 — Sep 2020 [monthly]

Active Not Recruiting PHASE3
Jul 2020 — Aug 2020 [monthly]

Active Not Recruiting PHASE3
Jun 2020 — Jul 2020 [monthly]

Active Not Recruiting PHASE3
May 2020 — Jun 2020 [monthly]

Active Not Recruiting PHASE3
Apr 2020 — May 2020 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Mar 2020 — Apr 2020 [monthly]

Recruiting PHASE3
Feb 2020 — Mar 2020 [monthly]

Recruiting PHASE3
Jan 2020 — Feb 2020 [monthly]

Recruiting PHASE3
Dec 2019 — Jan 2020 [monthly]

Recruiting PHASE3
Nov 2019 — Dec 2019 [monthly]

Recruiting PHASE3
Sep 2019 — Nov 2019 [monthly]

Recruiting PHASE3
Aug 2019 — Sep 2019 [monthly]

Recruiting PHASE3
Jul 2019 — Aug 2019 [monthly]

Recruiting PHASE3
Jun 2019 — Jul 2019 [monthly]

Recruiting PHASE3
Apr 2019 — Jun 2019 [monthly]

Recruiting PHASE3
Mar 2019 — Apr 2019 [monthly]

Recruiting PHASE3
Jan 2019 — Mar 2019 [monthly]

Recruiting PHASE3
Dec 2018 — Jan 2019 [monthly]

Recruiting PHASE3
Oct 2018 — Dec 2018 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Aug 2018 — Oct 2018 [monthly]

Not Yet Recruiting PHASE3
Jul 2018 — Aug 2018 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Agios Pharmaceuticals, Inc.

Data source: Agios Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amiens, France , Ankara, Turkey (Türkiye) , Atlanta, United States , Bangkok, Thailand , Barcelona, Spain , Berlin, Germany , Bordeaux, France , Boston, United States , Cambridge, United Kingdom , Cincinnati, United States and 33 more locations