Trials / Completed
CompletedNCT03853798
Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007
An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects With Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Agios Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mitapivat | Tablets |
Timeline
- Start date
- 2019-03-21
- Primary completion
- 2024-07-03
- Completion
- 2024-07-03
- First posted
- 2019-02-26
- Last updated
- 2025-11-18
- Results posted
- 2025-11-18
Locations
42 sites across 16 countries: United States, Brazil, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Netherlands, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03853798. Inclusion in this directory is not an endorsement.