Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Thalassemia, sponsored by Agios Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HR was defined as a ≥1.0 gram per deciliter (g/dL) increase in Hb concentration from Baseline at 1 or more assessments between Week 4 and Week 12 (inclusive). A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug.
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 |
What the registry record for NCT03692052 still lists
NCT03692052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 89-participant average among 19 other Thalassemia trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Thalassemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03692052's enrollment target sits among peer trials
20 15th of 19 higher than 3 of 19 other Thalassemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thalassemia 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
-
A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
RECRUITING · Phase 2
-
Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
COMPLETED · Phase 2
-
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies
COMPLETED · Phase 2
-
Stem Cell Transplant for Hemoglobinopathy
COMPLETED · Phase 2
-
Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI