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

Phase 3

Completed

• Conditions: Acute Liver Failure
• Interventions: Drug: N-acetylcysteine (NAC); Drug: Placebo

• Registration Number: NCT00004467
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine (NAC)	N-acetylcysteine (NAC)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Overall survival rate	3 weeks

Secondary Outcome Measures

Name	Time	Method
Survival without liver transplantation (Spontaneous Survival	3 weeks
Number of organ systems showing failure	3 weeks
Transplant rate	3 weeks
Length of hospital stay	3 weeks

Trial Locations

Locations (23)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Northwestern University Medical School; 🇺🇸 Chicago, Illinois, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Mount Sinai Medical Center, NY; 🇺🇸 New York, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

University of Michigan Health Systems; 🇺🇸 Ann Arbor, Michigan, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States