A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY II)

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY II)

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2018

At a glance

  • Drugs Actoxumab (Primary) ; Actoxumab/bezlotoxumab (Primary) ; Bezlotoxumab (Primary)
  • Indications Clostridium-difficile-infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MODIFY II
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 24 Apr 2018 Results of subgroup analysis assessing effects of bezlotoxumab in patients with solid tumour by using data from MODIFY I and II studies presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases.
    • 24 Apr 2018 Results of post-hoc subgroup analysis assessing effects of bezlotoxumab on patients with haematologic malignancy by using data from MODIFY I and II studies presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases.
    • 10 Mar 2018 Results of pooled post-hoc analysis by using data from two studies (MODIFY I and MODIFY II) published in the Clinical Infectious Diseases.
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