The Markers and Paracetamol Poisoning Study 2 (MAPP2)

November 14, 2023 updated by: NHS Lothian

The Markers and Paracetamol Poisoning Study 2 - Early Diagnosis of Drug-induced Liver Injury Using Point of Care Detection of microRNA

Paracetamol overdose is one of the most common medical emergencies. Annually in the UK, 100,000 people seek medical attention and 50,000 need hospital admission. Treatment is with the antidote acetylcysteine (NAC), which is effective but takes 21 hours to administer intravenously and frequently produces adverse reactions.

Current tools that are used to decide who needs treatment are inadequate. this trial team have identified and validated new blood tests that accurately identify those patients at risk of liver injury by quantifying the fundamental in vivo toxicity mechanisms.

This study aim to gain further samples in order to develop a new point-of-care test specifically for the detection of liver damage.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Paracetamol overdose is one of the most common medical emergencies. Annually in the UK, 100,000 people seek medical attention and 50,000 need hospital admission. Treatment is with the antidote acetylcysteine (NAC), which is effective but takes 21 hours to administer intravenously and frequently produces adverse reactions. Paracetamol is the commonest cause of acute liver failure and directly kills around 200 people/year in the UK. Management of paracetamol overdose is estimated to cost around £48 million/year to the NHS.

Current tools that are used to decide who needs treatment are inadequate. This trial team have identified and validated new blood tests that accurately identify those patients at risk of liver injury by quantifying the fundamental in vivo toxicity mechanisms. Over the last 4 years the team have published data in leading journals such as The Lancet, Lancet Gastroenterology (the MAPP Trial), Hepatology and Clinical Pharmacology & Therapeutics. The current gold standard marker, serum Alanine Aminotransferase Test (ALT) activity, lacks both sensitivity and specificity for early liver injury. This has resulted in being able to qualify 3 new liver biomarkers in over 1,200 patients (microRNA-122 (miR-122), High Mobility Group Box protein 1 (HMGB1) and keratin-18 (K18)) and demonstrated they predict liver injury at first presentation to hospital with high accuracy at a time when ALT is still normal.

This project develops a new point-of-care (POC) test for circulating microRNA specifically for the detection of liver damage after paracetamol overdose. The team have developed the microRNA biomarker (miR-122) to the point where it has received formal regulatory support from the USA Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The proposed assay has backing from worldwide clinical opinion leaders and pharma partners such as AstraZeneca, GSK and Novartis. The engineering solution for POC microRNA detection is underpinned by robust pilot data and field-leading expertise. The current assay for miR-122 is PCR following extensive sample preparation which is too slow for acute clinical decision making and for dose-escalation decisions. To address this key roadblock (as identified by the FDA) the team will use electrochemical impedance spectroscopy (EIS). the trial team have over 10 years of experience in EIS-based POC test development. Pilot data demonstrate that EIS can detect miR-122 spiked into buffer and distinguish patients with DILI (high miR-122) from healthy subjects (low miR-122).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to Emergency Department or Acute Medical Unit with paracetamol overdose

Description

Inclusion Criteria:

  1. Age 16 years and over.
  2. Hospital attendance with paracetamol overdose alone or as part of a mixed overdose
  3. Patient is able to give informed consent

Exclusion Criteria:

  1. Patient detained under the Mental Health Act
  2. Inability to provide informed consent
  3. Unreliable history of overdose
  4. Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To establish a biobank of human serum samples from patients with paracetamol overdose to develop and test the performance of our POC Test
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Lothian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Dear, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 244423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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