Hepatic Encephalopathy Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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