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NCT03692052 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia
A Phase 2 study of Thalassemia, sponsored by Agios Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 4
- Study locations
NCT03692052 is a Phase 2 study of Thalassemia that is active but no longer recruiting, run by Agios Pharmaceuticals. The registered enrollment target is 20 participants, below the 89-participant average among 19 other Thalassemia trials with a reported enrollment target (78% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03692052, a Phase 2 study of Thalassemia, is active but no longer recruiting, sponsored by Agios Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 4
- Study locations
Study Summary
Study AG348-C-010 is a multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of treatment with AG-348 in adult participants with non-transfusion-dependent thalassemia (NTDT). This study includes a core period (up to 24 weeks) followed by an extension period (up to 10 years) for eligible participants. 20 participants with NTDT were enrolled. The initial dose of AG-348 was 50 milligrams (mg) twice daily (BID) with one potential dose-level increase to 100 mg BID at the Week 6 visit based on the participant's safety and hemoglobin (Hb) concentrations.
Conditions Studied
Interventions
- DRUG AG-348
Study Locations (4)
California
- UCSF Benioff Children's Hospital Oakland - Oakland
Massachusetts
- Massachusetts General Hospital - Boston
Ontario
- University Health Network (Toronto General Hospital) - Toronto
Other
- Imperial College Healthcare NHS Trust (Hammersmith Hospital) - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03692052
The ClinicalTrials.gov registry entry for NCT03692052 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 89-participant average among 19 other Thalassemia trials with a reported enrollment target (78% lower). The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Thalassemia appearing as the primary indexed condition, and to 1 intervention - of which AG-348 is the first listed.
NCT03692052 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Massachusetts, Ontario.
Frequently Asked Questions
What is clinical trial NCT03692052 about?
NCT03692052 is a clinical study titled "A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia". Study AG348-C-010 is a multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of treatment with AG-348 in adult participants with non-transfusion-dependent thalassemia (NTDT). This study includes a core period (up to 24 weeks) followed by an extension period (up t...
What is the current status of trial NCT03692052?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-03-20. Estimated completion is 2030-09-30.
What conditions does trial NCT03692052 study?
This clinical trial studies the following conditions: Thalassemia.
What interventions are being tested in trial NCT03692052?
The interventions under investigation include: AG-348 (DRUG).
Who is sponsoring clinical trial NCT03692052?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03692052 being conducted?
This trial has 4 study locations across California, Massachusetts, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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