POP
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)
Sponsor study identifier
interventional
24
1 country
1
Study Start
June 8, 2017
Actual (reported)Primary Completion
August 8, 2018
Actual (reported)Study Completion
November 8, 2018
Actual (reported)Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 8, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2017
Actual (reported)June 6, 2017
Actual (reported)June 8, 2017
Actual (reported)August 8, 2018
Actual (reported)November 8, 2018
Actual (reported)October 3, 2019
Actual (reported)Safety Events
Adverse Events and Serious Adverse Events
90 days
ALT(U/L)
Baseline
ALT(U/L)
10 hours
ALT(U/L)
20 hours
INR
Baseline
INR
10 hours
NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian.
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: * Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC * Group B: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC * Group C: PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes.
PP100-01
NAC
Royal Infirmary of Edinburgh
Edinburgh, City Of Edinburgh, EH16 4SA, United Kingdom
Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13.
POP Trial Investigators; Dear J. Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial. Trials. 2019 Jan 8;20(1):27. doi: 10.1186/s13063-018-3134-1.
James Dear
University of Edinburgh
24 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2017
First Posted
June 6, 2017
Study Start
June 8, 2017
Actual (reported)Primary Completion
NAC Treatment and Outcomes in Patients With Advanced Atherosclerosis and DM
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
August 8, 2018
Actual (reported)Study Completion
November 8, 2018
Actual (reported)Last Updated
October 3, 2019
Results First Posted
October 3, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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