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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Texas |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00004467 |
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.
Condition | Intervention | Phase |
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Acute Liver Failure |
Drug: acetylcysteine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Enrollment: | 173 |
Study Start Date: | June 1998 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
This is a phase III blinded study, which will involve approximately 200 patients. For this purpose, acute liver failure will be defined as onset of any mental status alteration and coagulopathy (INR > 1.5) within 26 weeks of onset of a hepatitic illness, with no evidence of underlying chronic liver disease. Eligible patients will be those admitted to study site hospital intensive care units with acute liver failure and who can be evaluated and started on treatment within the first 24 hours of hospitalization or those who evolve to altered mentation if already in the hospital. All subjects will be between 18 and 70 years. Patients transferred from referring hospitals to a study site may be considered for enrollment, provided that no other specific treatment protocol has begun, and that no liver support device (BAL, ELAD, transgenic pig perfusion) has been used or is contemplated. Use of fresh frozen plasma infusions will not disqualify patients from participation.
Exclusion Criteria
In general, ALF patients comprise somewhat more women than men, but there is no preponderance of any racial group, other than that expected on the basis of geographic differences. No exclusion will be made on the basis of race, ethnic group or gender. Criteria for inclusion of women and minorities will be those established in the NIH guidelines. Each study site will provide for review a log of patients considered for the NAC study with no identifiers, yielding only gender and age, race and reason for not participating as a check on gender or ethnic bias.
Study Chair: | William M. Lee, MD | University of Texas |
Study ID Numbers: | 199/13925, UTSMC-1R03DK52827, UTSMC-IRB-0697-27200 |
Study First Received: | October 18, 1999 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00004467 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government; United States: Institutional Review Board |
acute liver failure gastrointestinal disorders rare disease |
Liver Failure Liver Diseases Antioxidants Gastrointestinal Diseases Rare Diseases Antiviral Agents Digestive System Diseases |
Liver Failure, Acute Expectorants Acetylcysteine N-monoacetylcystine Acetaminophen Hepatic Insufficiency |
Anti-Infective Agents Liver Failure Respiratory System Agents Liver Diseases Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Protective Agents Antiviral Agents Pharmacologic Actions |
Digestive System Diseases Liver Failure, Acute Expectorants Therapeutic Uses Free Radical Scavengers Acetylcysteine N-monoacetylcystine Antidotes Hepatic Insufficiency |