Clinical Trial

An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects With Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies

Dimensions: NCT03853798

Investigators

Affiliations

Organisations

  1. (1) Agios Pharmaceuticals (United States), grid.427815.d

Sponsors/collaborators

Abstract

This is a multicenter, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with AG-348 in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.

Methods

Condition: Pyruvate Kinase Deficiency

Intervention: Participants will receive 5, 20, or 50 mg twice a day for up to 192 weeks (not including dose taper) unless the dose is modified for reasons related to safety.

Recruitment information

Gender: All

Trial period

2019-2024

Phase

Phase 3

Research Categories

Main Subject Area

Fields of Research

External sources

Access at Registry