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A Multi-Center, Randomized, Open-Label, Parallel-Group Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia

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Trial Profile

A Multi-Center, Randomized, Open-Label, Parallel-Group Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 13 Aug 2021

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At a glance

  • Drugs Hepcidin (Primary)
  • Indications Iron overload
  • Focus Registrational; Therapeutic Use
  • Sponsors La Jolla Pharmaceutical Company

    • Most Recent Events

    • 28 Jul 2021 Dose of the study drug LJPC-401 has been reduced from 40 to 20 mcg, time point for the evaluation of primary end-point has been reduced from 52 to 26 weeks and minimum age for inclusion in the study is reduced from 18 to 14 years, thus including adolescents as well.
    • 28 Jul 2021 Status changed from recruiting to discontinued due to lack of efficacy as determined by interim endpoint analyses.
    • 16 Jun 2021 This trial is completed in Cyprus, according to European Clinical Trials Database record.

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