A Phase I Randomised, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study of the Tolerability and Pharmacokinetics of GBT440 in Healthy Subjects and Patients With Sickle Cell Disease

Trial Profile

A Phase I Randomised, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study of the Tolerability and Pharmacokinetics of GBT440 in Healthy Subjects and Patients With Sickle Cell Disease

Completed
Phase of Trial: Phase I/II

Latest Information Update: 19 Feb 2018

At a glance

  • Drugs Voxelotor (Primary)
  • Indications Sickle cell anaemia
  • Focus Adverse reactions
  • Acronyms HAEM 4174
  • Sponsors Global Blood Therapeutics
  • Most Recent Events

    • 13 Feb 2018 Status changed from active, no longer recruiting to completed.
    • 09 Jan 2018 According to a Global Blood Therapeutics media release, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to voxelotor for the treatment of sickle cell disease (SCD), based on data from this and other 3 studies.
    • 11 Oct 2017 According to a Global Blood Therapeutics media release, data were presented at the Academy for Sickle Cell and Thalassemia (ASCAT) 11th Annual Conference in London.
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