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A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile Associated Disease.

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Trial Profile

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile Associated Disease.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2022

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At a glance

  • Drugs Actoxumab/bezlotoxumab (Primary)
  • Indications Clostridium difficile infections; Diarrhoea
  • Focus Therapeutic Use
  • Sponsors MassBiologics

    • Most Recent Events

    • 30 Jun 2016 Results assessing risk factors for recurrence using data from the placebo arm (n = 99) published in the Clinical Infectious Diseases.
    • 27 Jan 2010 Results have been published in the New England Journal of Medicine.
    • 30 May 2009 Results have been presented at Digestive Disease Week 2009.

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