A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MITAPIVAT IN PEDIATRIC SUBJECTS WITH PYRUVATE KINASE DEFICIENCY WHO ARE NOT REGULARLY TRANSFUSED, FOLLOWED BY A 5-YEAR OPEN-LABEL EXTENSION PERIOD

Registry ID

AG348-C-023

Source registry

HEALTH_CANADA

Status

Ongoing

Phase

PHASE3

Study type

INTERVENTIONAL

Sponsor

AGIOS PHARMACEUTICALS INC

Start date

2025-02-17

Last update

2021-12-23

Conditions

• PYRUVATE KINASE DEFICIENCY

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• A ROLLOVER STUDY TO PROVIDE CONTINUED ACCESS TO MITAPIVAT FOR PARTICIPANTS WHO PREVIOUSLY COMPLETED AN AGIOS-SPONSORED MITAPIVAT STUDY
• A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MITAPIVAT IN PEDIATRIC SUBJECTS WITH PYRUVATE KINASE DEFICIENCY WHO ARE REGULARLY TRANSFUSED, FOLLOWED BY A 5-YEAR OPEN-LABEL EXTENSION PERIOD

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