PP100-01 (Calmangafodipir) for Overdose of Paracetamol

• Status: Completed
• Trial end date: 2018-11-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Egetis Therapeutics; PledPharma AB
• Collaborators: NHS Lothian; University of Edinburgh
• Treatments: Acetaminophen; Acetylcysteine; Edetic Acid; N-monoacetylcystine; Pyridoxal Phosphate

Criteria

Inclusion Criteria:

1. Any patient with capacity admitted to hospital within 24 hrs either a single acute POD or more than one dose of paracetamol (staggered) and deemed to require treatment with NAC.

2. Provision of written informed consent

3. Males and females of at least 16 years of age

Exclusion Criteria:

1. Patients that do not have the capacity to consent to participate in the study

2. Patients detained under the Mental Health Act or deemed unfit by the Investigator to participate due to mental health.

3. Patients with known permanent cognitive impairment

4. Patients who are pregnant or nursing

5. Patients who have previously participated in the study

6. Unreliable history of POD

7. Patients presenting after 24hrs of POD

8. Patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an overdose of anticoagulants

9. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to complete the full course of NAC e.g. expressing wish to self-discharge

10. Prisoners

11. Non-English speaking patients. (Study information material will only be produced in English in view of the known and stable demographic of the Edinburgh self-harm population).