A phase I study for determination the efficacy of an abbreviated, patient-tailored course of intravenous N-acetylcysteine (NAC) in preventing hepatotoxicity from paracetamol overdose

A phase I study for determination of the efficacy of an abbreviated, patient-tailored course of intravenous N-acetylcysteine (NAC) in preventing hepatotoxicity from paracetamol overdose

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-TCH-10000949

Enrollment

Unknown

Registered

2010-07-02

Start date

2010-07-03

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatotoxicity from paracetamol overdose

Interventions

Total:N-acetyl cysteine

Eligibility

Sex/Gender

Male

Age

21 Years to 90 Years

Inclusion criteria

Inclusion criteria: Paracetamol overdose taken withing 8 hours, serum levels exceeting the 150 mg/L toxic line on Rumack-Matthew nomogram

Exclusion criteria

Exclusion criteria: 1. Patients who are unconscious or clinically unstable; 2. Patients 90 y/o. (Inclusion age 21-90 yrs); 3. Abnormal liver function tests at the outset or abnormal at 12 hrs; 4. Active/chronic hepatitis disease of viral or other causes or Liver cirrhosis; 5. Patients with known liver failure; 6. Patients with known renal failure; 7. IV NAC started after 12 hours of overdose; 8. Patients who took significant potentially toxic co-ingestants (except ethanol or benzodiazepines); 9. Pregnant patients; 10. Actively suicidal; 11. Personality Disorder.

Design outcomes

Primary

Measure	Time frame
hepatotoxicity;	—

Countries

Singapore

Contacts

Public ContactGregory Cham

gregory_cham@ttsh.com.sg+65-63578777

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026