CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 20 enrolled
Drug / intervention
AG-348drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03692052
NCT03692052Phase 2Active
CompareCT.gov

A Phase 2, Open-label, Multicenter Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Subjects With Non-transfusion-dependent Thalassemia

Agios Pharmaceuticals, Inc.·interventional·Posted Oct 2, 2018·Updated Mar 30, 2026

In Brief

A Phase 2 clinical trial evaluating AG-348 for Thalassemia. Active but no longer recruiting, targeting 20 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThalassemia
CountriesCanada, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
2019202020212022202320242025202620272028202920302031
First PostedOct 2, 2018
Enrollment StartMar 20, 2019
Primary CompletionAug 20, 2020
Study CompletionSep 30, 2030
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.8 years ago

Interventions

AG-348drug

AG-348 tablet orally BID