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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ACETADOTE

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Clinical Trials for Acetadote

Trial ID Title Status Sponsor Phase Summary
NCT00374088 N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) Completed University of Michigan Phase 2 The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major heart surgery, such as the arterial switch operation, routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This heart dysfunction may be severe and contributes to an increased risk for death or prolonged hospitalization. Current standard treatments include intravenous medications such as dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart function. Unfortunately, high doses of these medications have the potential to cause severe side effects including loss of fingers and toes, liver and kidney dysfunction, and heart rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart surgery in order to promote a smoother postoperative period, and reduce the risks associated with heart operations in children.
NCT00397735 N-acetylcysteine in Intra-amniotic Infection/Inflammation Unknown status Yale University Phase 1/Phase 2 The aim of the study is to determine if N-acetylcysteine (a potent free radical scavenger) prevents the occurrence of adverse neonatal outcomes in preterm deliveries complicated by infection associated with preterm labor or preterm premature rupture of membranes (PPROM). The working hypothesis is that in pregnancies complicated by intra-amniotic infection or inflammation, N-acetylcysteine protects the fetus by preventing the development, or decreasing the intensity and/or progression of the fetal inflammatory syndrome.
NCT00939913 Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy Unknown status Cumberland Pharmaceuticals Phase 4 In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC. This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com). Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.
NCT00939913 Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy Unknown status Ochsner Health System Phase 4 In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC. This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com). Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.
NCT01118663 Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection Terminated Cumberland Pharmaceuticals Phase 3 The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
NCT01808521 A Pilot Study of N-acetylcysteine in Thrombotic Thrombocytopenia Purpura Enrolling by invitation University of Washington Phase 0 In this study, the investigators want to determine if N-acetylcysteine(NAC), given intravenously, will decrease complications in patients with Thrombotic Thrombocytopenia Purpura (TTP) who are receiving treatment with therapeutic plasma exchange (TPE). The investigators want to determine, through anti-oxidant activity, if NAC will have additional efficacy in TTP by improving cleavage of the patients' VWF by ADAMTS13, and preventing propagation of platelet/VWF strings. This will be manifest by a more rapid improvement in the patient's platelet count, decrease in number of days requiring TPE, and decrease in microvascular thrombotic complications. The investigators will additionally: 1) Assess safety of NAC by evaluating subjects for adverse events and significant adverse events 2) Determine effects on TTP by measuring clinical and research laboratory values 3) Determine drug effects by measuring clinical and research laboratory values.
NCT01808521 A Pilot Study of N-acetylcysteine in Thrombotic Thrombocytopenia Purpura Enrolling by invitation Bloodworks (Puget Sound Blood Center) Phase 0 In this study, the investigators want to determine if N-acetylcysteine(NAC), given intravenously, will decrease complications in patients with Thrombotic Thrombocytopenia Purpura (TTP) who are receiving treatment with therapeutic plasma exchange (TPE). The investigators want to determine, through anti-oxidant activity, if NAC will have additional efficacy in TTP by improving cleavage of the patients' VWF by ADAMTS13, and preventing propagation of platelet/VWF strings. This will be manifest by a more rapid improvement in the patient's platelet count, decrease in number of days requiring TPE, and decrease in microvascular thrombotic complications. The investigators will additionally: 1) Assess safety of NAC by evaluating subjects for adverse events and significant adverse events 2) Determine effects on TTP by measuring clinical and research laboratory values 3) Determine drug effects by measuring clinical and research laboratory values.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Acetadote

Condition Name

Condition Name for Acetadote
Intervention Trials
Transposition of Great Vessels 1
Congenital Heart Disease 1
Nephropathy 1
Sickle Cell Disease 1
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Condition MeSH

Condition MeSH for Acetadote
Intervention Trials
Purpura, Thrombotic Thrombocytopenic 1
Transposition of Great Vessels 1
Neoplasms 1
Obstetric Labor, Premature 1
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Clinical Trial Locations for Acetadote

Trials by Country

Trials by Country for Acetadote
Location Trials
United States 15
Belgium 1
United Kingdom 1
Netherlands 1
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Trials by US State

Trials by US State for Acetadote
Location Trials
California 2
Louisiana 2
Connecticut 2
Michigan 2
Washington 1
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Clinical Trial Progress for Acetadote

Clinical Trial Phase

Clinical Trial Phase for Acetadote
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Acetadote
Clinical Trial Phase Trials
Completed 2
Unknown status 2
Enrolling by invitation 1
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Clinical Trial Sponsors for Acetadote

Sponsor Name

Sponsor Name for Acetadote
Sponsor Trials
Cumberland Pharmaceuticals 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 1
Centre Hospitalier Régional de la Citadelle 1
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Sponsor Type

Sponsor Type for Acetadote
Sponsor Trials
Other 20
Industry 2
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