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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: Completed Phase 3 study, sponsored by Agios Pharmaceuticals.
NCT03853798 is a Phase 3 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A clinical adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the study drug. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and include both serious and non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Ev
Interventions
- DRUG Mitapivat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-03-21 |
| Est. Completion | 2024-07-03 |
| Phase | Phase 3 |
What the finished NCT03853798 record still lists
NCT03853798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Mitapivat is the first listed.
NCT03853798 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03853798's enrollment target sits among peer trials
90 1724th of 2000 higher than 263 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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