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Sponsored by: |
Hyperion Therapeutics, Inc. |
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Information provided by: | Hyperion Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00597909 |
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
Condition | Intervention | Phase |
---|---|---|
Hepatic Encephalopathy |
Drug: sodium phenylacetate and sodium benzoate injection 10% / 10% Drug: placebo solution (10% dextrose) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Two Doses of AMMONUL® (Sodium Phenylacetate and Sodium Benzoate) Injection 10% / 10% in Subjects With Grade 3 or 4 Hepatic Encephalopathy |
Estimated Enrollment: | 105 |
Study Start Date: | December 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: sodium phenylacetate and sodium benzoate injection 10% / 10%
5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
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2: Experimental |
Drug: sodium phenylacetate and sodium benzoate injection 10% / 10%
2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
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3: Placebo Comparator |
Drug: placebo solution (10% dextrose)
Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
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Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome seen in patients with liver disease. The pathogenesis of HE is incompletely understood, but several pieces of evidence identify ammonia as a key factor in the development of HE. The liver normally detoxifies ammonia produced in the gastrointestinal tract. However, in patients with cirrhosis, portosystemic shunting allows ammonia to bypass the liver and reach the systemic circulation and the brain. The accumulation of ammonia in the brain, through mechanisms not yet fully defined, lead to changes of consciousness, intellectual function, and behavior. Ammonul is currently approved as adjuvant therapy for the management of hyperammonemia and associated encephalopathy in patients with deficiencies in the enzymes of the urea cycle. Ammonul removes nitrogenous ammonia in these patients through pathways alternative to the urea cycle. It is anticipated that in patients with HE, Ammonul may lead to the scavenging of ammonia through these alternative biochemical pathways taking place in tissues other than the liver. This study is designed to test the efficacy and safety of IV Ammonul® as a treatment for acute episodes of elevated ammonia in patients with Grade 3 or 4 HE.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSF-Fresno University | |
Fresno, California, United States, 93721 | |
Loma Linda University Medical Center | |
Loma Linda, California, United States, 92354 | |
United States, Texas | |
Permian Research Foundation | |
Odessa, Texas, United States, 79761 |
Study Director: | Bruce Scharschmidt, MD | Hyperion Therapeutics, Inc. |
Responsible Party: | Hyperion Therapeutics, Inc. ( Bruce Scharschmidt, MD, Senior Vice President and Chief Medical Officer ) |
Study ID Numbers: | HYP1203-004 |
Study First Received: | January 9, 2008 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00597909 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ammonul® sodium phenylacetate and sodium benzoate hepatic encephalopathy Grade 3 or 4 Hepatic Encephalopathy |
Antimetabolites Anti-Infective Agents Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Sodium Benzoate Signs and Symptoms Mental Disorders Antifungal Agents Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations |
Hepatic Insufficiency Delirium Liver Failure Metabolic Diseases Benzoates Phenylacetic acid Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Antimetabolites Anti-Infective Agents Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Neurotoxicity Syndromes Antineoplastic Agents Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Brain Diseases Sodium Benzoate Signs and Symptoms Mental Disorders Antifungal Agents |
Therapeutic Uses Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure Metabolic Diseases Benzoates Phenylacetic acid Nervous System Diseases Poisoning Central Nervous System Diseases Confusion Pharmacologic Actions Encephalitis Virus Diseases |