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NCT03853798 · ClinicalTrials.gov registry record · Phase 3

Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007

A Phase 3 study, sponsored by Agios Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
90
Enrollment target

NCT03853798 is a Phase 3 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 90 participants.

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The verdict

NCT03853798, a Phase 3 study, has completed, sponsored by Agios Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
90 participants
Enrollment target

Study Summary

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

Interventions

  • DRUG Mitapivat

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2019-03-21
Est. Completion 2024-07-03
Phase Phase 3

Sponsor

Agios Pharmaceuticals

44 total trials

What the Registry Record Tells You About NCT03853798

The ClinicalTrials.gov registry entry for NCT03853798 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Mitapivat is the first listed.

NCT03853798 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03853798 about?

NCT03853798 is a clinical study titled "Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007". This is an open-label, multicenter, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with mitapivat in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.

What is the current status of trial NCT03853798?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2019-03-21. Estimated completion is 2024-07-03.

What interventions are being tested in trial NCT03853798?

The interventions under investigation include: Mitapivat (DRUG).

Who is sponsoring clinical trial NCT03853798?

This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.