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A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 66 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 29 versions Re-verified since Oct 10, 2023, no change to tracked fieldsv38-v66
  2. Start date: Dec 28, 2018 to Mar 20, 2019v37
  3. 12 versions Re-verified since Jan 27, 2022, no change to tracked fieldsv25-v36
  4. Results first posted: Nov 15, 2021 Primary completion date changed from estimate of Sep 30, 2030 to Aug 20, 2020 · Secondary endpoints: 14 to 20 · Eligibility criteria shortened, about 2 wordsv24 Show 3 more changesShow less
    • Primary completion date changed from estimate of Sep 30, 2030 to Aug 20, 2020
    • Secondary endpoints: 14 to 20
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. 5 versions Re-verified since Nov 18, 2020, no change to tracked fieldsv19-v23
Show 2 earlier versionsHide 2 earlier versions
  1. Primary and study completion dates: Aug 28, 2022 to Sep 30, 2030 Secondary endpoints revised (14)v18 Show 1 more changeShow less
    • Secondary endpoints revised (14)

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv17
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03692052
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Thalassemia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov