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NCT03559699 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)
A Phase 3 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
NCT03559699 is a Phase 3 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 27 participants.
The verdict
NCT03559699, a Phase 3 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
Study Summary
Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.
Interventions
- DRUG AG-348
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2020-11-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03559699
The ClinicalTrials.gov registry entry for NCT03559699 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 27 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 AG-348 is the first listed.
NCT03559699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03559699 about?
NCT03559699 is a clinical study titled "A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)". Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, D...
What is the current status of trial NCT03559699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2018-06-26. Estimated completion is 2020-11-12.
What interventions are being tested in trial NCT03559699?
The interventions under investigation include: AG-348 (DRUG).
Who is sponsoring clinical trial NCT03559699?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
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