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)
Phase of Trial: Phase I
Latest Information Update: 22 Feb 2018
At a glance
- Drugs Calmangafodipir (Primary) ; Acetylcysteine
- Indications Drug toxicity; Liver dysfunction; Liver failure
- Focus Adverse reactions; Proof of concept
- Acronyms The POP Trial
- Sponsors PledPharma
- 22 Feb 2018 According to a PledPharma media release, first two patients were dosed in third cohort.
- 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.