Phase 1
N=24
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Paracetamol Overdose
Bottom Line
View on ClinicalTrials.gov: NCT03177395 ↗Enrolled (actual)
24
Serious AEs
45.8%
Results posted
Oct 2019
Primary outcome: Primary: Safety Events — 6; 6; 6; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PP100-01 (calmangafodipir) (Drug); Acetylcysteine (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Egetis Therapeutics
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Events |
6; 6; 6; 6; 2; 4 | — |
| SECONDARY ALT(U/L) |
43.3; 20.4; 25.4; 16.4 | — |
| SECONDARY ALT(U/L) |
43.3; 20.4; 25.4; 16.4 | — |
| SECONDARY ALT(U/L) |
43.3; 20.4; 25.4; 16.4 | — |
| SECONDARY INR |
1.15; 1.07; 1.10; 1.10 | — |
| SECONDARY INR |
1.15; 1.07; 1.10; 1.10 | — |
| SECONDARY INR |
1.15; 1.07; 1.10; 1.10 | — |
| SECONDARY INR |
1.15; 1.07; 1.10; 1.10 | — |
| SECONDARY Additional NAC Infusion |
3; 5; 6; 6; 1; 1 | — |
| SECONDARY K18 (U/L) |
1.85; 1.29; 0.89; 1.41 | — |
| SECONDARY K18(U/L) |
182; 152; 170; 111 | — |
| SECONDARY K18 (U/L) |
1.85; 1.29; 0.89; 1.41 | — |
| SECONDARY K18 (U/L) |
1.85; 1.29; 0.89; 1.41 | — |
| SECONDARY ccK18 (U/L) |
2.22; 1.49; 1.02; 1.08 | — |
| SECONDARY ccK18 (U/L) |
2.22; 1.49; 1.02; 1.08 | — |
| SECONDARY ccK18 (U/L) |
2.22; 1.49; 1.02; 1.08 | — |
| SECONDARY ccK18 (U/L) |
2.22; 1.49; 1.02; 1.08 | — |
| SECONDARY miR-122 (Delta Count) |
4.85; 7.12; 4.49; 8.44 | — |
| SECONDARY miR-122 (Delta Count) |
4.85; 7.12; 4.49; 8.44 | — |
| SECONDARY miR-122 (Delta Count) |
4.85; 7.12; 4.49; 8.44 | — |
| SECONDARY miR-122 (Copies/mcL) |
1.48; 0.49; 1.04; 1.13 | — |
| SECONDARY miR-122(Copies/mcL) |
206,205; 109,882; 196,732; 37,066 | — |
| SECONDARY miR-122 (Copies/mcL) |
1.48; 0.49; 1.04; 1.13 | — |
| SECONDARY miR-122 (Copies/mcL) |
1.48; 0.49; 1.04; 1.13 | — |
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.
Eligibility Criteria
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
- 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
- Prisoners
- 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).
Data sourced from ClinicalTrials.gov (NCT03177395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.