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NCT03548220 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)
A Phase 3 study, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT03548220 is a Phase 3 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 80 participants.
The verdict
NCT03548220, a Phase 3 study, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.
Interventions
- DRUG Placebo
- DRUG AG-348
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2020-10-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03548220
The ClinicalTrials.gov registry entry for NCT03548220 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 80 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 2 interventions - of which Placebo is the first listed.
NCT03548220 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03548220 about?
NCT03548220 is a clinical study titled "A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)". Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.
What is the current status of trial NCT03548220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2018-08-09. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT03548220?
The interventions under investigation include: Placebo (DRUG), AG-348 (DRUG).
Who is sponsoring clinical trial NCT03548220?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
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