A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE β0-THALASSEMIA

Trial Profile

A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE β0-THALASSEMIA

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2018

At a glance

  • Drugs Glutamine (Primary)
  • Indications Sickle cell anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Emmaus Medical
  • Most Recent Events

    • 12 Mar 2018 According to a Emmaus medical media release, Company's Marketing Authorization Application (MAA) for Xyndari has been fully validated and is now under assessment by the European Medicines Agency (EMA) for the treatment of sickle cell disease.
    • 12 Dec 2017 Results assessing efficacy and tolerability of L-glutamine in patients with sickle cell anaemia or sickle thalassaemia, were presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 28 Nov 2017 According to an Emmaus Life Sciences medis release, data will be presented at the 59th Annual Meeting of the American Society of Hematology (ASH).
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