NCT00004467

Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.

Detailed description

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive intravenous acetylcysteine or placebo for 72 hours. Treatment must begin within 12 hours of hospitalization. Patients who advance to grade III or IV encephalopathy are eligible for liver transplantation. Patients are followed at 3 weeks.

Conditions

• Acute Liver Failure

Interventions

Type	Name	Description
DRUG	N-acetylcysteine (NAC)	Infusion of 5% dextrose with N-acetylcysteine with an initial loading dose of 150 mg/kg/h of NAC over 1 hour, followed by 12.5 mg/kg/h for 4 hours, then continuous infusions of 6.25 mg/kg/h for the remaining 67 hours.
DRUG	Placebo	Infusion of 5% dextrose

Timeline

• Start date: 1998-06-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 1999-10-19
• Last updated: 2017-10-13

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study