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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR ACETYLCYSTEINE

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Clinical Trials for Acetylcysteine

Trial ID Title Status Sponsor Phase Summary
NCT00003346 Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.
NCT00003346 Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma Completed Memorial Sloan Kettering Cancer Center Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of acetaminophen plus carmustine in treating patients who have stage III or stage IV melanoma.
NCT00004467 Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen Completed University of Texas Phase 3 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.
NCT00004467 Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 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.
NCT00028262 Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children. At around 11 to 13 months of age, patients develop slowed head growth, mild brain atrophy (wasting), electroencephalographic (EEG) changes and retinal deterioration, with symptoms worsening over time. The disease results from an enzyme deficiency that causes fatty compounds called ceroid to accumulate in cells. In laboratory experiments, Cystagon has helped remove ceroid from cells of patients with INCL. Children with INCL between 6 months and 3 years of age may be eligible for this study. Participants take Cystagon daily by mouth every 6 hours. They are admitted to the NIH Clinical Center for a 4- to 5-day period every 6 months for the following tests and evaluations: - Review of medical history, including a detailed record of seizures, physical examination, blood tests and clinical photographs. For the initial baseline studies, examinations may also be scheduled with pediatric neurology, ophthalmology and anesthesia services. - Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves, and computers to provide detailed images of the brain without the use of X-rays. The patient lies on a table that slides inside a donut-shaped machine containing a magnetic field. The child requires general anesthesia for the procedure. - Electroretinogram (ERG) measures the function of the retina, the light-sensitive tissue in the back of the eye. To record the flash ERG, a special contact lens is placed on the eye s surface and the eye is stimulated with flashes of light. Infants and very young children require general anesthesia for the procedure. - Visual evoked potential (VEP) measures the function of the visual pathway from the eye to the brain. To record the VEP, five electrodes are placed on the scalp and the eye is stimulated with flashes of light. Infants and very young children must be anesthetized for the procedure. - Electroencephalogram (EEG) measures brain electrical activity, using electrodes placed on the scalp. The test is useful in defining seizures. The child may need to be sedated to keep still during the test. - Skin biopsy A small piece of skin is removed (usually from the upper arm or shoulder) under local anesthetic to grow cells in the laboratory. This procedure is done at the start of the study and is repeated after 1 year if therapy results are promising. Children s condition may improve, stabilize or worsen during this study. Life may be prolonged without significant improvement in quality. The information gained from the study may help scientists develop more potent drugs to treat INCL.
NCT00122018 An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery Completed Abbott Phase 2 Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
NCT00122018 An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery Completed Linda F. Barr, M.D. Phase 2 Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Acetylcysteine

Condition Name

Condition Name for Acetylcysteine
Intervention Trials
Chronic Kidney Disease 8
Contrast Induced Nephropathy 7
Acute Renal Failure 5
Helicobacter Pylori Infection 5
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Condition MeSH

Condition MeSH for Acetylcysteine
Intervention Trials
Kidney Diseases 36
Renal Insufficiency 28
Acute Kidney Injury 20
Disease 19
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Clinical Trial Locations for Acetylcysteine

Trials by Country

Trials by Country for Acetylcysteine
Location Trials
United States 242
Italy 19
Canada 14
Brazil 13
Taiwan 11
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Trials by US State

Trials by US State for Acetylcysteine
Location Trials
South Carolina 20
Texas 17
Minnesota 16
California 16
Connecticut 14
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Clinical Trial Progress for Acetylcysteine

Clinical Trial Phase

Clinical Trial Phase for Acetylcysteine
Clinical Trial Phase Trials
Phase 4 57
Phase 3 37
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Acetylcysteine
Clinical Trial Phase Trials
Completed 131
Recruiting 43
Unknown status 41
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Clinical Trial Sponsors for Acetylcysteine

Sponsor Name

Sponsor Name for Acetylcysteine
Sponsor Trials
Medical University of South Carolina 15
Yale University 11
National Institutes of Health (NIH) 9
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Sponsor Type

Sponsor Type for Acetylcysteine
Sponsor Trials
Other 380
NIH 39
Industry 28
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
McKesson
Healthtrust
Cipla
Harvard Business School
Boehringer Ingelheim
Daiichi Sankyo
AstraZeneca
Cerilliant

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