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

NCT03853798 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-18

Study results available
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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.

Conditions

  • Pyruvate Kinase Deficiency

Interventions

DRUG

Mitapivat

Tablets

Sponsors & Collaborators

  • Agios Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Affairs · Agios Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2024-07-03
Completion
2024-07-03
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • Switzerland
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853798 on ClinicalTrials.gov