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
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Diagnostics devices play an important part in the clinical assessment of a patient’s health and treatment. The purpose of the study is the evaluation of a new diagnostic platform developed by LumiraDx. The evaluation is focused around various biomarkers useful in the emergency settings.
Collection of venous and capillary blood samples for the evaluation of new diagnostic devices for cardiovascular conditions