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A Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care in Patients Hospitalized for Babesiosis

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Trial Profile

A Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care in Patients Hospitalized for Babesiosis

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Dec 2024

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At a glance

  • Drugs Tafenoquine (Primary)
  • Indications Babesiosis
  • Focus Registrational; Therapeutic Use
  • Sponsors 60 Degrees Pharmaceuticals

Most Recent Events

  • 11 Dec 2024 According to a 60 Degrees Pharma media release, at least 24, and as many as 33 patients, will be recruited in the summer of 2025, with an interim analysis anticipated early in 2026. The interim analysis will include both a test of significance, and size re-estimation to allow additional recruitment if required.
  • 11 Dec 2024 According to a 60 Degrees Pharma media release, company announced today it has entered into a clinical trial agreement with Brigham and Women's Hospital (BWH) in Boston to conduct a double-blind, placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized babesiosis patients.The clinical site is led by Brigham and Women's Hospital researchers Ann Woolley, M.D., and David Leaf, M.D.
  • 19 Jul 2024 According to a 60 Degrees Pharma media release, sufficient enrollment capacity is planned to allow all study subjects to be recruited before the end of the 2025 tick season (traditionally, from June to September). The interim analysis will include both a test of significance, as well as size re-estimation to allow additional recruitment if required.

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