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The POP Trial

Start date:
June 2017
End date:
December 2017
Co-ordinated by:
EMERGE, RIE
Main trial site:
RIE

Paracetamol can be harmful to the liver when an excessive dose has been taken. To help prevent liver damage, an antidote known as acetylcysteine is given. However a few patients can develop liver damage even if they get acetylcysteine. This study will give a new drug (calmangafodipir) in combination with acetylcysteine to see if using these two drugs together is safe and if it is better at preventing damage to the liver than using acetylcysteine only. If you take part you will receive either acetylcysteine and calmangafodipir or acetylcysteine alone.

As a secondary objective possible efficacy will be explored by using experimental biomarkers in serum/plasma, such as CK18 and microRNA MiR122, GLDH, mitochondrial DNA and others that might give efficacy signals for PP100-01. The diagnosis of paracetamol/acetaminophen overdose will be made by ALT and paracetamol/acetaminophen measurements.
This study includes several comparisons;
• Safety and tolerability of PP100-01 + NAC vs NAC alone
• Assess hepatotoxicity in patients after POD as assessed using ALT, INR and experimental biomarkers of liver damage

Chief Investigator

Dr James Dear

Consultant in Acute Medicine & Toxicology

Research Team

Bernadette Gallagher

Senior Research Nurse

Kat Oatey

ECTU Trial Manager

Julia Grahamslaw

Lead Research Nurse

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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