The ASTUTE Trial ("AST-120 Use for the Treatment of Hepatic Encephalopathy") is a Phase 2 multi-site, randomized, double-blind, placebo-controlled 8-week study in up to 150 patients with MHE. Patients will be evaluated on neurocognitive improvement at the end of the study, defined as the change in the global summary score of the RBANS or Repeatable Battery for the Assessment of Neuropsychological Status.
"The ASTUTE trial will use a battery of neuropsychometric tests to assess the efficacy of AST-120 in an MHE population," said Scott Harris, M.D., Ocera's chief medical officer, "Up to 60 percent of patients with cirrhosis have MHE and impaired neurocognitive function, a condition for which no drugs are approved."
AST-120 is a novel microspherical carbon adsorbent with a selective adsorption profile for a variety of unwanted substances in the digestive tract. These substances may be responsible for a number of conditions, including Hepatic Encephalopathy (HE), Irritable Bowel Syndrome (IBS), and pouchitis. They include ammonia, indoles (serotonin, octopamine), histamine, secondary bile acids, advanced glycation endproducts (AGE), and certain bacterial toxins. Ocera licensed the compound from the Kureha Corporation (Japan) in 2005.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, based in San Diego, California, USA, is a privately held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic liver diseases and a broad range of gastrointestinal disorders. In addition to AST-120, Ocera is developing OCR-002 in he
|SOURCE Ocera Therapeutics, Inc.|
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