CompletedPhase 1

PP100-01 (Calmangafodipir) for Overdose of Paracetamol

United Kingdom24 participantsStarted 2017-06-08

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Provision of written informed consent
✓. Males and females of at least 16 years of age

Exclusion criteria

✕. Patients that do not have the capacity to consent to participate in the study
✕. Patients detained under the Mental Health Act or deemed unfit by the Investigator to participate due to mental health.
✕. Patients with known permanent cognitive impairment
✕. Patients who are pregnant or nursing
✕. Patients who have previously participated in the study
✕. Unreliable history of POD
✕. Patients presenting after 24hrs of POD
✕. Patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an overdose of anticoagulants

What they're measuring

Safety Events

Timeframe: 90 days

Trial details

NCT IDNCT03177395

SponsorEgetis Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-08

Results submitted2019-07-30

View on ClinicalTrials.gov More Paracetamol Overdose trials