An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Trial Profile

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2017

At a glance

  • Drugs Tecovirimat (Primary)
  • Indications Orthopoxvirus infections; Smallpox
  • Focus Adverse reactions; Registrational
  • Sponsors SIGA Technologies
  • Most Recent Events

    • 02 Mar 2017 Status changed from active, no longer recruiting to completed.
    • 29 Aug 2016 According to a SIGA Technologies media release, the company anticipates submitting the complete New Drug Application (NDA) for TPOXX™ to the FDA by the end of 2017 and will seek an expedited review of its submission.
    • 29 Aug 2016 According to a SIGA media release, enrollment and dosing in the final cohort of this trial has been completed.
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