A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial)

Trial Profile

A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial)

Recruiting
Phase of Trial: Phase I

Latest Information Update: 20 Oct 2017

At a glance

  • Drugs Calmangafodipir (Primary) ; Acetylcysteine
  • Indications Liver dysfunction; Liver failure
  • Focus Adverse reactions; Proof of concept
  • Acronyms The POP Trial
  • Sponsors PledPharma
  • Most Recent Events

    • 20 Oct 2017 According to a PledPharma media release, company received approval from Data Safety and Monitoring Board for start of recruitment in the second cohort.
    • 30 Aug 2017 According to a PledPharma media release, 8 out of 24 patients completed their treatment in this trial.
    • 12 Jun 2017 Status changed from not yet recruiting to recruiting
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